MONITORING CONSCIOUSNESS DURING PERIOD OF SEDATION

LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

FACULTY OF NURSING

DEPARTMENT OF NURSING AND CARE

STEBYMOL THOMAS

MONITORING CONSCIOUSNESS DURING PERIOD OF

SEDATION

The graduate thesis of the Master‘s degree study programme “Advance Nursing practice“ (state code:6211GX008)

Tutor of the graduate thesis MD, PhD Laima Juozapaviciene

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TABLE OF CONTENT

ABSTRAC... 3

ABBREVATION... 5

1. INTRODUCTION... 6

2. AIM AND OBJECTIVES... 7

3. LITERATURE REVIEW... 7

3.1. The importance sedation during regional anaesthesia... 7

3.2. Medicines for sedation... 3.2.1. Midazolam for sedation... 10

3.2.2. Propofol for sedation... 3.2.3. Techniques of intravenious sedation... 11 12 3.3. Monitoring vital function during sedation... 13

3.4. Monitoring consciousness during sedation... 18

3.5. Patients satisfaction during intra-operative period... 3.6. Nurse role... 21 21 4. METHODOLOGY OF A RESEARCH... 23 5. RESULTS... 25 5. 1. Patients characteristics... 24

5.2. The comparison sedation effects between midazolam and propofol... 26

5.3. The comparison haemodinamics parameters between midazolam group and propofol group... 27

5.4. The comparison the incidence of respiratory depression between midazolam and propofol group... 28

5.5.Satisfaction score of the sedation... 29

6. DISCUSION OF THE RESULTS... 31

7. CONCLUSIONS... 34

8. PRACTICAL RECOMMENDATIONS... 35

LIST OF SCIENTIFIC REPORTS PUBLICATIONS... 36

LIST OF LITERATURE SOURCES... 37 ANNEXES

DECLARATION OF THE AUTHOR‘S CONTRIBUTION AND ACADEMIC HONESTY...

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MONITORING CONSCIOUSNESS DURING PERIOD OF SEDATION

Lithuanian University of Health Sciences, Department of Nursing and Care,

Faculty Advanced Nursing practice

Introduction. The increased use of regional anaesthesia in recent years has led to an increased need for sedation during surgery in awake patients. Sedation is known to increase patient’s acceptance of regional anaesthesia and to greatly improve patient wellbeing during the surgical procedure. The global tolerance of regional block has been shown to be better with sedation than without. Moreover, continuous sedation will help to increase comfort, specially during long surgery or uncomfortable positioning. Sedation was associated with a significant improvement in patient satisfaction.

Aim and objectives. The aim of this study is to investigate to level consciousness during period of sedation and satisfaction score. Objectives: 1.To compare the effects sedation between midazolam and propofol, if they were used by sedation doses. 2. To compare haemodinamics parameters between midazolam group and propofol group 3. To compare the incidence of respiratory depression between midazolam and propofol 4. To evaluate satisfaction score of the sedation.

Materials and methods. The observational study was conducted out in the Departments of Anaesthesiology, Lithuanian University of Health Sciences. The study included 61 patients undergoing surgery (minor proctology, urology and reconstructive surgery) in regional anaesthesia (periferal regional anaesthesia or spinal anaesthesia) with sedation. Midazolam to 0.2 mg/kg - 2 to 3 mg/kg IV in an adult max 5 mg IV or Propofol 1 mg/kg IV, can repeat doses of ¼ to ½ of first dose as needed to maintain desired level of sedation. The patients were continuously monitored for cardiorespiratory function (e. g., mean arterial blood pressure, pulse rate, breathing rate, and SpO2), pain and consciousness data, patients satisfaction scale. The follow-up data were recorded every 15 min (during the first hour of anaesthesia) and every 30 min thereafter or during the adverse event cases (respiratory rate < 8 or > 30 times per min, SpO2 < 90 %, a hypotensive event was predefined as an arterial systolic blood pressure reading 30 % below basal levels). The first measurement was at the time of operating room admission before start of anaesthesia (0 min). A six - point sedation scale (modified Ramsay scale) was used to evaluate depth of sedation, a five – point scale was used for satisfaction scale. Permission by Bioethics Center of Lithuanian Health Sciences University No

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BEC-ISP(M)-197 was received for reseach. Descriptive statistics used for statistics quantitative data: frequences and average values were analyzed; nonparametric data analysis testes were applied.

Results. The were no significant differences in demografic data or regional anaesthesia method (periferal regional block and spinal anaesthesia) between two groups. Mean sedation scores of patiens in group P (propofol) were signifantly higher than those of patients in group M (midazolam) (p=0.001). Patients in both groups experienced a significant decrease in arterial systolic blood pressure during sedation (group P p=0.0018 and group M p=0.0032) for both groups, although the difference between groups was not significant (p=0.105). Oxygen saturation as measured by pulse oximetry deceased to < 95% but still >90% in 9 patients (28%) in group P and 7 (24%) in group M (p=0.62). Firstly, verbal and stimulation were used to trigger breathing, then supplemental oxygen was given via nasal cannula 4-6 l/min. The most serious hypoxia with low SpO2 levels <90% was noted in 6 (19.3%) and 3 (10.3%) in groups P and groups M, respectively (p=0.311). Suplement oxygen was given via face mask and airway opening maneuvers performed in 5 patients. The patients’s satisfaction was not different in two groups (mean satisfaction score in group P 4.62±0.35 and group M 4.52±0.36, p=0.85).

Conclusions. The results of study shows that the sedation level was higher in propofol group. The difference in haemodynamical and respiratory events between the propofol and midazolam groups were not significant. The patients’s satisfaction were similar in both groups.

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ABBREVATION

BP - arterial blood pressure PR – pulse rate

RR - respiratory rate SpO2 – saturation

ECG – electrocardiogram IV – intravenous

POVN – post – operative nausea and vomiting TCI – target controlled infusion

PCS – patient controlled sedation PMS – patient maintained sedation

OAAS – Observers’ Assessment of Alertness/Sedation scale UMSS – University of Michigan Sedation Scale

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1. INTRODUCTION

Anxiety and fear, and the possibility of pain, towards a sometimes unknown surgical procedure may lead to emotional stress for the patient, varying from suppressed fear of pain, and other stress related symptoms to a phobia which can make surgical treatment impossible. Patients may even show physical signs of increased sympathetic stimulation such as sweating, hypertension, tachycardia and tremors. These symptoms and signs may lead to anxiety-induced cardiac arrhythmias, hypertension, cerebrovascular accidents and /or vaso-vagal reactions, especially in the medically compromised patient [1]. The increased use of regional anaesthesia in recent years has led to an increased need for sedation during surgery in awake patients. Sedation is known to increase patient’s acceptance of regional anaesthesia and to greatly improve patient wellbeing during the surgical procedure [2, 3]. Sedation is part of the general management of a patient receiving a regional block and being awake during the whole surgical procedure. The aims include general patient comfort, freedom from specific discomfort, and some amnesia for both the block procedure and the surgical operation, in order to meet the patient’s preference and safety [3]. The global tolerance of regional block has been shown to be better with sedation than without. Moreover, continuous sedation will help to increase comfort, specially during long surgery or uncomfortable positioning. Sedatives can help to decrease the requirement of opioid analgesics which contributes to the reduction of postoperative nausea and vomiting [4, 5]. Sedation was associated with a significant improvement in patient satisfaction [6]. It has been shown that sedation allows the choice of a shorter anaesthetic method (e.g. local or regional anaesthesia vs spinal or general anaesthesia), which improves time to recovery and discharge [7]. But sedation does involve some risks, especially induction of respiratory depression, haemodynamic instability, or uncontrolled movements [8]. Therefore, monitoring of vital functions and warning of possible after operational events during sedation is very important. Also, it is imporant to monitor the depth of sedation all the time, to reach for the most optimal and safe effect for the patient.

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2. AIM AND OBJECTIVES

2. 1. Aim of research

The aim of this sudy is to investigate to level consciousness during period of sedation and satisfaction score.

2. 2. Objectives of research

1. To compare the effects sedation between midazolam and propofol, if they were used by sedation doses.

2. To compare haemodinamics parameters between midazolam group and propofol group. 3. To compare the incidence of respiratory depression between midazolam and propofol.

4. To evaluate satisfaction score of the sedation and compare between midazolam group and propofol group.

3. LITERATURE REVIEW

3.1. The importance sedation during regional anaesthesia

Regional anaesthesia reduces postoperative mortality and other serious complications. A. Rodgers, et al. study found reductions in risk of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression, and renal failure when patients were operated in neuraxial blocade [9]. Postoperative complications increase healthcare utilization (e.g. hospital length of stay, unplanned admission to intensive care or high-dependency units, and hospital readmission), mortality, and adverse discharge to a nursing home. Furthermore, they are associated with significant costs. Center-specific treatment guidelines may reduce risks and can be guided by a local champion with multidisciplinary involvement. Patients should be risk-stratified before surgery and offered anesthetic choices (such as regional anesthesia) [10]. For the anaesthetist, cardiovascular and respiratory stability, rapid postoperative recovery, and preservation of protective airway reflexes are the most important advantages of regional anaesthesia. Sedation is part of the general management of a patient receiving a regional block and being awake during the whole surgical procedure. The aims include general patient comfort, freedom from specific discomfort, and some amnesia for both the block procedure and the surgical operation, in order to meet the patient’s preference and safety [3]. Better knowledge of different properties of sedative

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drug has made sedation under regional anaesthesia more effective and safer. Sedation is used in wide variety of surgical procedures like orthopedics, gynecology, paravertebral blocks, ophthalmology, urology, other gastrointestinal procedures, ICU and dentistry. Sedation also increases comfort level of the patient and acceptance of regional anaesthesia. It decreases the analgesic requirement so improving recovery of the patient. Sedation has been shown to increase patient satisfaction during regional anaesthesia and it is a valuable tool to make it more convenient for patient, anesthesiologist and the surgeon. It also reduces postoperative recall. So sedated and cooperative patient is of great importance in regional anaesthesia [3, 4, 16].

Sedation is a continuum ranging from mild anxiolysis to unconsciousness and unresponsiveness. There are multiple reasons why sedation during regional anaesthesia procedures is advantages:

 Sedation alleviates the stress associated with fear of needles, procedural pain, and recall of the nerve block [11,12].

 Sedation increases patient satisfaction during regional anaesthesia and increase global tolerance of regional blocks [13,14].

 Sedation decrease the requirement for opioid analgesics, potentially reducing the risk of opioid-related adverse events such as nausea (POVN) [4, 5].

 Sedation with benzodiazepines or propofol increase the seizure threshold, thereby potentially reducing the risk of central nervous systemic toxicity [15].

Sedation is not without risk, particularly respiratory and hemodynamic depression, highlighting the need for appropriate monitoring and access to resuscitation drugs and equipment. There is also a risk of sedating a patient to a level of consciousness where disinhibition and unexpected movement could occur during the block, resulting in injury [17].

Characteristic for ideal sedative agents:  Rapid onset of action.

 Easy titration.

 Short context sensitive half time

 Rapid elimination from body.

 Minimal cardiorespiratory depression and other side effects.

 Lack of tolerance and withdrawal symptoms.

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3.2. Medicines for sedation

Table 3.2.1. Commonly used sedative drugs during regional anaesthesia

Drugs Onset (min) Notes

Midazolam 1-2

Rapid anxiolysis. Associated with anterograde amnesia. Especially in higher doses. Synergistic depression of respiratory function with opioids. Minimal residual effect.

Propofol <1

Potent respiratory depressant, must be prepared for apnea.

Quick, clean offset with no “May have to re-dose depending on the length of procedure (i.e, multiple catheters).

Fentanyl 3-5

Some sedation when given alone. Excellent analgesic. Associated with facial pruritis.

Etomidate <1

Etomidate's popularity in anesthetic practice lies in its limited effects on cardiovascular and hemodynamic function even in patients with co-morbid diseases, as compared with other intravenous anesthetic agents (propofol and the barbiturates)

Ketamine <5

1–1.5 mg/kg Unique features of ketamine, which make it particularly attractive for procedural sedation, include the provision of amnesia, sedation, immobilization and profound analgesia along with limited deleterious effects on hemodynamic and respiratory function.

Dexmedetomidine 5-10

Prolongs sensory block, good sedative. Faster offset than clonidine

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3.2.1. Midazolam

The benzodiazepines bind to receptor sites in the GABA system, increasing the efficacy of the interaction between GABA, its receptor, and the chloride channel. Midazolam is the benzodiazepine most frequently used for procedural sedation. A short-acting, water-soluble benzodiazepine, an ideal agent for its amnestic and anxiolytic properties. Midazolam, with a half-life of 2 hours, has limited cardiovascular effects, allows for quick recovery and vomiting. It is a short-acting, water-soluble agent which provides reliable anxiolysis, sedation and amnesia. Of clinical note, the benzodiazepines as a group, provide no analgesia, and so are often co-administered with opioids, generally fentanyl, because of their similar pharmacokinetic profiles (rapid onset and offset), which are desirable during procedural sedation. Benzodiazepine metabolism occurs via hepatic oxidation and glucuronidation with the potential prolongation of their effects in patients with hepatic dysfunction.

Dose: 0.05 – 0.1 mg/kg; 0.03 – 0.2 mg/kg/h infusion.

Drowsiness, decrease anxiety, and to decrease your memory of the surgery or procedure. This medication may also be used to help with anaesthesia or to sedate people who need a tube or machine to help with breathing. Midazolam works by calming the brain and nerves. It belongs to class of drugs known as benzodiazepines.

How to use Midazolam?

This medication is given by slow injection into a vein or muscle as directed by your doctor. It is usually given by a health care professional. The dosage is based on your medical condition, type of procedure you are having, other medications you are receiving, age, weight, and response to treatment. Effective sedation with midazolam can be provided by multiple routes of administration including oral, intranasal, rectal, intramuscular, and intravenous delivery. The benzodiazepines can have adverse effects on respiratory and hemodynamic function. These effects occur in a dose-dependant fashion and are modified by morbid diseases and the synergistic effect of administration with other sedative/analgesic agents such as the opioids. When midazolam is co-administered with an opioid, the sedation plan should include titration to effect beginning with a lower dose of midazolam (0.05 mg/kg). Other clinically significant adverse effects include paradoxical excitement which may occur in up to 10–15% of patients [18]. These effects can be particularly alarming to family members and staff, as they are completely opposite in nature to the desired and expected results.

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Side effects of Midazolam include: ● Headache, ● Nausea, ● Vomiting ● Cough, ● Drowsiness ● “over sedation”

● Injection site reactions (pain, swelling, redness, stiffness, blood clots and tenderness).

3.2.2. Propofol

Midazolam and Propofol are commonly used for moderate sedation during a variety of medical procedures.

Propofol (2,6-di-isoprophylphenol) is commonly classified as an intravenous anesthetic agent. Because of its insolubility in water, it is commercially available in an egg lecithin emulsion as a 1% (10 mg/mL) solution. Its chemical structure is distinct from that of the barbiturates and other commonly used anesthetic induction agents. Propofol is a sedative/amnestic agent, possesses no analgesic properties, and should be combined with an opioid or ketamine (commonly known as “ketofol”) when analgesia is required. Like the barbiturates, its effects are mediated through the GABA receptor system by increasing chloride conductance across the cell membrane.

The anesthetic induction dose of propofol in healthy adults ranges from 1(1.5) to 3 mg/kg with recommended maintenance infusion rates varying from 50 to 200 μg/kg/minute (3–6 mg/kg/h), depending on the depth of sedation that is required.

Following intravenous administration, propofol is rapidly cleared from the central compartment and undergoes hepatic metabolism to inactive water-soluble metabolites, which are then renally cleared. Its rapid redistribution, clearance, and metabolism provide rapid awakening when the infusion is discontinued.

Although initially introduced for anesthetic induction and maintenance, propofol's pharmacodynamic profile including a rapid onset, rapid recovery time, and lack of active metabolites has accounted for its popularity in the arena of procedural sedation [19]. In addition to its favorable properties with regard to sedation and recovery times, propofol has beneficial effects on CNS dynamics, including a decreased cerebral metabolic rate for oxygen cerebral vasoconstriction, and lowering of intracranial pressure [20, 21] These effects are clinically similar to those seen with the barbiturates and etomidate. Given these effects, propofol may be

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an effective and beneficial agent for sedation in patients with altered intracranial compliance due to traumatic brain injury, provided that the patient is receiving ventilatory support to prevent increases in PaCO2 related to the respiratory depressant properties of propofol.

Like many of the sedative/analgesic agents, propofol has significant respiratory depressant effects, which may be exacerbated by its combination with other agents (e.g., opioids). Propofol shifts the CO2 response curve to the right, but unlike the opioids, does not depress the slope. A similar effect is seen with the administration of barbiturates or benzodiazepines. Reports regarding the use of propofol for procedural sedation in spontaneously breathing patients demonstrate a high incidence of respiratory effects including hypoventilation, upper airway obstruction, and apnea. Clinically significant respiratory effects include upper airway obstruction due to effects on upper airway (pharyngeal) musculature, hypoventilation with hypercarbia, hypoxemia, and/or apnea. These effects are dose dependent and more likely with higher doses as deeper levels of sedation/anesthesia are achieved. There is significant interpatient variability regarding the dose required to induce any of these adverse respiratory events.

Propofol decreases mean arterial pressure (MAP) related to both peripheral vasodilation and negative inotropic properties [22]. Propofol alters baroreflex responses, resulting in a smaller increase in heart rate for a given decrease in blood pressure. These cardiovascular effects are especially pronounced following bolus administration. Although well tolerated by patients with adequate cardiovascular function, these effects may result in detrimental physiologic effects in patients with compromised cardiovascular function.

Additional cardiovascular effects relate to propofol's augmentation of central vagal tone leading with the potential for bradycardia or even asystole when combined with other medications that decrease cardiac chronotropic function (fentanyl, succinylcholine) [23, 24]. Given the potential for respiratory and hemodynamic effects, although generally safe and effective when used by practitioners with advanced airway training and experience in procedural sedation, appropriate monitoring and ready access to equipment for emergency airway management and cardiovascular resuscitation is mandatory.

3.2.3. Techniques of intravenious sedation

Generally four types of techniques are used for sedation under regional anaesthesia:

1. Initial bolus dose followed by continuous infusion. It may lead to rising blood concentration over a time and it requires repeated adjustment of infusion rates to maintain desired level of

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sedation. It is traditionally given by the anesthesiologist in monitored anesthesia care[25, 26].

2. Target controlled infusion (TCI): In this method, infusion to the patient is given based on achieving calculated blood concentration as a target and when the target is achieved the infusion pump either stopped or slowdown. These days newer algorithms used in TCI are based on effect site concentration as a target and have resulted in faster onset with better control of drug effects. It is observed that an effect-site concentration of propofol of 0.4–0.8 µg/ml and 0.5–1.0 ng/ml for remifentanil can produce adequate sedation in most cases [26, 27].

3. Patient controlled sedation (PCS): In this method, patient control delivery of sedation by a button which is linked to the pump to deliver the desired drug. Patient may increase or decrease the rate depending upon the requirement. This method is also having safety feature of lock out period which is usually of 1 – 3 minutes. Patients are free to control their own level of sedation. No drug is delivered during this lock out period. Till date this method is considered as better over the other methods because the patient satisfaction is higher and total consumption of sedative agent is also less [28, 26].

4. Patient maintained sedation (PMS): In this newer method the patient has the option to increase the target concentration in target controlled infusion method as per their needs. Main drawback of this method is slow onset of sedation and no standard recommendation has been established till now. However, some studies have strong preference for PMS [26, 29].

3.3. Monitoring vital function during sedation

Given that respiratory and hemodynamic effects may occur with any agent by any route, means to identify such problems are mandatory in all patients who receive procedural sedation. Given the importance of such monitoring in identifying adverse effects of sedative and analgesic agents, several organizations representing pediatrics, anesthesiology and emergency medicine have published procedural sedation guidelines which include sections suggesting appropriate monitoring during and after the administration of such medications [30, 31]. Of equal importance in the monitoring of patients during the procedure is to continue monitoring throughout the recovery phase. Once the stimulus of the painful procedure is completed, apnea or airway obstruction may occur due to the residual effects of the sedative/analgesic agents. Practically, this is particularly relevant, for example, after completion of an orthopedic reduction when frequently the patient is transported to the Radiology Department for postreduction films. It is important that diligent monitoring is continued during the transport, while in the Radiology Department, and upon the

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patient's return to the Emergency Department to monitor for and address the complications that may arise.

The guidelines suggested by these physician organizations recommend that the administration of sedation, with or without analgesia, which may be reasonably expected to result in the potential for loss of airway protective reflexes, mandates the implementation of anesthesia standards for patient monitoring. The most important component of monitoring during procedural sedation is to have one person whose only job is to sedate and monitor the patient. The practitioner performing the procedure cannot act as both the monitor and sedation provider. As in the operating room, the hemodynamic, respiratory and oxygen saturation monitors are meant as a supplement to the person whose job it is to watch the patient. When feasible, this person should have an unobstructed view of the patient's face, mouth, and chest wall throughout the procedure.

Routine monitoring during procedural sedation should include continuous pulse oximetry and ECG monitoring as well as intermittent recordings of respiratory rate and blood pressure at a frequency of at least every 5 minutes during the procedure. This may be decreased as the patient regains consciousness during the recovery phase. Additionally, some ongoing monitoring of respiratory function is suggested such as observation of the patient's chest moving, use of a precordial stethoscope to auscultate breath sounds or use of an EtCO2 monitor. All these monitors have limitations and the practitioner must be cognizant of these and not rely on the monitors solely to assess the patient's well-being.

Pulse oximetry remains the most widely used monitor during procedural sedation. The currently available oximeters are calibrated for oxygen saturation (SaO2) values over 80% and lose their accuracy at values less than 75% [32]. In the majority of patients, this is not of clinical significance, given that their SaO2 values would normally be in the upper 90% range; however, this may become an issue when sedating patients with residual cyanotic congenital heart disease where SaO2 values of 70–80% are common. Additional issues that may interfere with continuous pulse oximetry readings include patient movement or poor perfusion states. Patient movement may be interpreted as pulsatile flow resulting in inaccurate readings or prohibiting any meaningful measurement of oxygen saturation [33]. To identify such issues, it is recommended that pulse oximeters which display the plethysmography tracing be used. Placement of the oximeter probe on cool extremities or in patients with decreased peripheral perfusion may also limit the accuracy of pulse oximetry. Finally, there may be a significant delay between the development of hypoxemia and its registration by the pulse oximeter. Many of these issues have been addressed by the newest generation of pulse oximetry technology and by the development of forehead reflectance sensors, which appear to be more rapidly responsive and less sensitive to motion artifact and extremity temperature [33, 34].

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Some authorities have begun to recommend the use of continuous EtCO2 monitoring as a way to recognize apnea sooner than it would be detected by pulse oximetry (60–90 second delay). EtCO2 monitoring utilizes infrared technology and the differential absorption or refraction of infrared light by the CO2 particles in the exhaled gas. This generates a waveform that is displayed with each exhalation. If there is central or obstructive apnea, the waveform immediately extinguishes and the healthcare provider is immediately alerted to the fact that there is no longer gas exchange. Additionally, as the CO2 content of the expired gas correlates fairly well with arterial CO2 values, increasing hypercarbia from over-sedation can be recognized. Although initially used only in intubated and mechanically ventilated patients, refinements in the technology have led to the production of specialized nasal cannulae which allow for EtCO2 monitoring in spontaneously breathing patients without an artificial airway. Several clinical studies have demonstrated the early identification of respiratory depression using this technology and have clearly indicated its superiority over pulse oximetry in many clinical scenarios [35, 36].

The greatest threat to the safety of a sedated patient is airway compromise and /or respiratory arrest. To decrease the risk of airway and respiratory complications, careful attention must be directed towards the appropriate selection of medications, adherence to dosing recommendations. Regardless of the clinical scenario or the medications used, appropriate monitoring of the patients respiratory and physiologic functions is mandatory to rapidly identify respiratory compromise. As intervention may be necessary, immediate access to appropriate medications and equipment should be assured. In anticipation of respiratory adverse events, appropriate preparation and monitoring may help detect respiratory depression or upper airway obstruction and allow the opportunity for intervention to prevent further mobility or mortality. Summary: The use of standard monitors such as pulse oximetry , electrocardiography, and arterial blood pressure measurement are routinely recommended for any type of anesthetic (regional or general). As such, monitoring of oxygenation and ventilation is critical in order to detect hypoventilation, airway obstruction, and/or hypoxemia from excessive sedation. Pulse oximetry and frequent verbal contact with the patient are often sufficient to ensure adequate gas exchange; however, many centers employ capnography during peripheral nerve blockade in order to have a graphical representation of respiratory rate and guard against apnea. Electrocardiography (EKG) and blood pressure monitoring are essential in monitoring for early signs of cardiovascular systemic local anesthetic toxicity. Cardiac toxicity from local anesthetics typically begins with myocardial depression followed by an increase in heart rate, blood pressure, and contractility that coincides with the onset of central nervous system excitement [37].

Supplemental oxygen should also be administered, either by face mask or nasal cannulae. Hypoxia has been shown to potentiate the negative chronotropic and inotropic effects of both

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lidocaine and bupivacaine, worsening the hemodynamic status during cardiotoxicity. Similarly, hypercapnia and acidosis from hypoventilation serve to increase the free fraction of bupivacaine in the plasma, as well as increase cerebral blood flow, two factors that may contribute synergistically to the development of systemic toxicity and seizures [38].

Should airway, hemodynamic or respiratory events occur during sedation, prompt identification and intervention is generally effective in reversing these adverse events before permanent sequelae can occur. The first step in this process occurs before the procedure starts, with the assurance that the appropriate equipment is available for resuscitation should such problems occur. The resuscitation equipment and medications should be readily available in the procedure area. If patients are sedated in one area and moved to a second area for their procedure, a stocked equipment cart should either be available in both areas or a portable cart should be available to take with the patient. Prior to the administration of any sedative agent, some of this equipment should be set out within arms reach or set-up including an appropriately sized bag-valve-mask device, Yankauer suction system, and monitoring devices. In most cases, an intravenous cannula is placed for the administration of sedative agents and resuscitation medications when needed. When sedation is provided by the administration of oral medications, the placement of an intravenous catheter is optional and can be placed after the administration of the oral sedative and topical anesthetic cream. However, when deep sedation is planned, even if administered via the inhalation or oral routes, a functioning intravenous catheter should be placed in most cases.

A variety of resuscitation equipment and medication should be immediately available during the performance of all regional blocks and during sedation in order to facilitate rapid control of the airway, termination of seizures, stabilization of vital signs, and treatment of the cardiotoxic effects of local anesthetic-induced systemic toxicity . This list should include the following [38]:

1. Self-inflating bag-valve-mask (i.e., Ambu bag) 2. Suction

3. An oxygen source with face mask

4. Endotracheal tube(s), oral, and/or nasal airways 5. Laryngoscope (tested and functioning)

6. Emergency drugs:

 A “sleep” dose of induction agent (e.g., 20 ml of propofol)  Succinylcholine

 Atropine

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 A 500-ml bag of intralipid for treatment of local anesthetic systemic toxicity (this does not necessarily have to be bedside but should be immediately available should the need arise to use it).

The primary response to airway and hemodynamic complications should be guided by general resuscitation guidelines such as those provided by pediatric advanced life support (PALS) or advanced cardiac life support (ACLS). Appropriate management of the ABCs (airway, breathing and circulation) is the priority. Treatment begins with the administration of supplemental oxygen if hypoxemia develops. A progressive management approach may then include repositioning of the airway or placement of a nasal airway to relieve upper airway obstruction, the application of continuous positive airway pressure (CPAP) to relieve laryngospasm, or bag-valve-mask ventilation for apnea. Following these resuscitation maneuvers, if an ongoing sedation infusion is being used, the infusion should be discontinued if the patient is still showing signs of possible airway or respiratory compromise. As needed, additional help should be summoned to aid in the resuscitation. Frequently, airway, hemodynamic or respiratory events are short-lived following the administration of a bolus dose of a medication and resolve spontaneously once the plasma concentration dissipates. Rarely, endotracheal intubation and controlled ventilation are needed. Given the possibility that such care may be needed, personnel skilled in such procedures should be readily available. Those providing sedation should be trained in the basics of advanced life support techniques including bag-valve-mask ventilation. In some instances, reversal of opioids with naloxone or benzodiazepines with flumazenil may be indicated.

Naloxone and its longer acting analogue, nalmefene, are pure μ-receptor antagonists and therefore can be used to reverse both the analgesic/sedative effects and side effects of opioids acting at the μ receptor. Naloxone is rapidly distributed, metabolized by glucuronide conjugation, and excreted in the urine, with a half-life of approximately 1 h in children and adults and 90 minutes to 3 h in neonates. The long half-life of some opioids compared to the short half-life of naloxone may require repeated doses or an infusion to avoid renarcotization. In addition to its shorter half-life, naloxone has lower affinity for μ receptors than most opioids, therefore it leaves the site of action more rapidly than even the shorter half-life would predict.

Nalmefene is a naltrexone derivative that is a pure opioid antagonist without agonist effects. It has a longer duration of effect than naloxone and is a more potent antagonist than naloxone at all three main types of opioid receptors. Nalmefene is four times as potent as naloxone in antagonizing effects at the μ receptor and more potent than naloxone in antagonizing effects at the κ receptor. It is commonly stated that opioid antagonists such as naloxone and nalmefene have essentially no pharmacologic or physiologic effects in patients who have no opioids in their system. Doses as high as 4 mg/kg have been administered intravenously to healthy adult volunteers, without adverse

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physiologic effects. However, reversal of opioid sedation/respiratory depression with these drugs has been associated with significant complications including pulmonary edema, tachycardia, hypertension, and even death. Although these adverse effects are particularly prominent in children and young adults in whom pain is still present, they are unlikely to occur in the procedural sedation arena when these agents are used to reverse the acute effects of opioid administration. In addition to hemodynamic changes, seizures have been reported after naloxone administration, but only in patients with CNS pathology, receiving relatively large doses.

Flumazenil is the only benzodiazepine antagonist currently available for clinical use. It competitively binds to central benzodiazepine receptors, thereby inhibiting GABA receptor activation. Whereas naloxone and nalmefene reverse both sedation and respiratory depression, flumazenil primarily reverses sedation with less effect on respiratory depression. Flumazenil is only recommended for intravenous administration in the treatment of acute benzodiazepine intoxication; however, anecdotal experience suggests that intranasal administration may also be feasible. Flumazenil is relatively lipophilic, resulting in a rapid onset of action (1–2 minutes). Similar to naloxone, the duration of activity (40–80 minutes) is shorter than that of most benzodiazepines, so there is a risk of resedation. The recommended dose is from 10–20 μg/kg every 1–2 minutes to a maximum of 1 mg. Adverse effects occur in approximately 5% of patients and include agitation, crying, aggression, headache, nausea and dizziness. Flumazenil is contraindicated in patients receiving chronic benzodiazepine therapy, as it may precipitate seizures or withdrawal. Seizures may also occur if flumazenil is given to patients who have ingested or are being treated with other medications which lower the seizure threshold (tricyclic antidepressants, methylxanthines, and cyclosporine). Flumazenil has been reported to precipitate ventricular dysrhythmias when administered concomitantly with cocaine, methylxanthines, monoamine oxidase inhibitors, chloral hydrate, and tricyclic antidepressants. Despite the efficacy of both naloxone and flumazenil in reversing the sedative and respiratory depressant effects of opioids and benzodiazepines, their availability does not diminish the need for prompt detection of hypoventilation/hypoxemia and the ability to intervene by establishing an airway and assisting ventilation [26].

3. 4. Monitoring consciousness during sedation

In addition to monitoring vital signs and cardiorespiratory function, there are also benefits to monitoring the efficacy and depth of the sedation provided. Patient comfort during procedures has become increasingly recognized as a major factor in determining what is considered adequate sedation. Sedation is a continuum ranging from mild anxiolysis to unconsciousness and unresponsiveness.

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Levels of sedation as described by the American Society of Anesthesiologists (Practice guidelines) [39]:

Non-dissociative sedation

• Minimal sedation and analgesia: essentially mild anxiolysis or pain control. Patients respond normally to verbal commands.

• Moderate sedation and analgesia (formerly known as “conscious sedation”): patients are sleepy but also aroused by voice or light touch. Although their airway and respiration are self maintained, these may be suppressed with deeper levels of sedation (which is a

continuum).

• Deep sedation and analgesia: patients require painful stimuli to evoke a purposeful response. Airway or ventilator support (or both) may be needed.

• General anaesthesia: patient has no purposeful response to even repeated painful stimuli. Airway and ventilator support is usually required. Cardiovascular function may also be impaired.

Additionally, the greatest risk to patient safety is not under-sedation, but rather over-sedation. As such, a means of accurately assessing the depth of sedation remains important. During lighter planes of sedation, the depth of sedation may be assessed by the patient's ability to appropriately respond to questions or verbal stimuli. For deeper levels of sedation, a variety of sedation scales have been developed to better quantify the degree of unconsciousness. Such scales include:

 Observers’ Assessment of Alertness/Sedation (OAAS) scale,

 Vancouver Sedative Recovery Scale,

 University of Michigan Sedation Scale (UMSS),

 modified Wilson scale,

 Ramsay scale.

The modified Ramsay scale, a variant of the Wilson and Ramsay scales, has an interratter agreement of 84% and is quick and simple to use in clinical practice. Although it has more items than other scales, it may be the best choice precise assessment of sedation is required [42].

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The use of BIS for monitoring conscious sedation is a topical subject. Originally developed for use in the operating room, the BIS monitor uses a specific algorithm to analyze the modified EEG and thereby assess the hypnotic effects of sedative and anesthetic agents. Based on various features of the EEG, a number is assigned ranging from 0 (isoelectric EEG) to 100 (fully awake). Although validated and used most commonly for intraoperative use, there may be a future role for BIS monitoring during procedural sedation as a means of evaluating the depth of sedation and perhaps avoiding over-sedation and respiratory compromise [26, 40, 41].

Factors influencing the level of sedation. Several studies have shown that spinal and epidural anaesthesia can reduce anaesthetic requirements and induce sedation. Listening to music is known to relax patients undergoing regional anaesthesia and has been shown to reduce the consumption of sedatives and to decrease perioperative pain scores, but not have any anxiolytic effect. Patients’ satisfaction was significantly higher when listening to music and almost all the patients would choose music again in future for similar surgery. In the setting of regional anaesthesia, hypnosis has been used to provide light sedation and amnesia. However, success of this technique was limited by the need of supplementary analgesics [3].

3.5. Patients satisfaction during intra-operative period

Patient satisfaction is a complex concept that may incorporate many dimensions including sociodemographic,cognitive, and affective components.Sedation has been shown to increase patient satisfaction during regional anaesthesia and may be considered as a means to increase the patients acceptance of regional anaesthesia, sedation is a valuable tool to make it more convenient for the

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patient, the anaesthetist, and the surgeon. Patient satisfaction has become an important endpoint in outcomes research. In the field of anesthesiology, assessment of patient satisfaction may be an important outcome measurement and indicator of quality of anesthesia care [45]. Patient satisfaction is important while doing interventions of pain management or sedation. It is usually assessed by a verbal rating scale from 0=completely dissatisfied to 5-10=completely satisfied. This is helpful to measure reflecting the ratio between expectation and occurrence of events. Patient satisfaction with sedation has been investigated widely and is generally very high. The investigations described earlier repeatedly stress the importance of “strict aseptic technique” before epidural catheterization or other regional techniques. However, the concept of what is essential for asepsis remains controversial [3, 44]. There are different indications for sedation or analgesia/sedation in the context of regional anaesthesia. It is helpful to have a calm and cooperative patient during placement of the block and decreases from the response to needle puncture or electric stimulation. There are no controlled studies of sedation as a means of supplementing an incomplete block, but general anaesthesia is needed if an additional block or opioids do not improve analgesia.

3.6. Nurse role

The sedative techniques used for regional anaesthesia have been exported outside the operating room to improve the quality of many different procedures. This evolution has revised first the problem of anaesthesiologist availability to cover this increasing number of procedures and second to delegate the practice of sedation in certain settings to well trained nurses.

Earlier An. study has shown that a nurse-implemented sedation protocol in operation theatre results in less mechanical ventilation, fewer ICU and hospital days, and a lower number of patients requiring. A more recent investigation in the same contest demonstrated that nurse role was associated with statistical significance.

Nicole Jones, et al. 2011 to introduce the role of nurse sedationist. It has been successfully introduced in an Australian acute public hospital. The introduction of the role has assisted to address an increased demand for anaesthetic services and to address patient safety concerns. Advanced practice nursing roles have expanded significantly due to changes in health care and workforce configuration. The nurse sedationist is an advanced practice role that has been developed in part to address an increased demand for services during a time of medical workforce shortage. An increased demand for services and varying levels of skill mix mean patients may be exposed to inferior levels of care. For example, patients may experience procedural sedation from healthcare workers who were not appropriately trained in the administration of sedation [46].

22 Table 3.6.1. Key stakeholder feedback: establihes benefits from introduction of the nurse

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4. METHODOLOGY OF A RESEARCH

The study was conducted out in Departments of Anaesthesiology, Lithuanian University of Health Sciences. This study was a observational study. The study included patients undergoing surgery in regional anaesthesia with sedation.

The local bioethics committee at the Lithuanian University of Health Sciences (former Kaunas University of Medicine) approved the study protocol (No. BE-2-77).

The inclusion criteria were: 1. Patients age18 years and older.

2. Patients undergoing surgery in regional anaesthesia (peripheral regional or spinal anaesthesia) . The exclusion criteria were:

1. General anaesthesia.

2. Regional anaesthesia without sedation.

The study included 61 patients undergoing surgery (minor proctology, urology and reconstructive surgery) in regional anaesthesia (periferal regional anaesthesia or spinal anaesthesia) with sedation.

In the operating room, after routine monitors including non – invasive blood pressure (BP) monitor, electrocardiogram, and pulse oximeter were attached to the patients, baseline vital signs were recorded. All patients received 10 ml/kg of Ringer lactate.

Midazolam to 0.2 mg/kg - 2 to 3 mg/kg IV in an adult max 5 mg IV or Propofol 1 mg/kg IV, can repeat doses of ¼ to ½ of first dose as needed to maintain desired level of sedation.

The patients were continuously monitored for cardiorespiratory function (e. g., arterial blood pressure (BP), pulse rate (PR), respiratory rate (RR), and saturation (SpO2), consciousness data. The follow-up data were recorded every 15 min (during the first hour of anaesthesia) and every 30 min thereafter or during the adverse event cases (respiratory rate < 8 or > 30 times per min, SpO2 < 90 %, a hypotensive event was predefined as an arterial systolic blood pressure reading 30 % below basal levels). The first measurement was at the time of operating room admission before start of anaesthesia (0 min).

Airway patency and respiratory functions were followed and maintained from commencement of procedure and sedation until discharge. If a decrease in SpO2, 94% occurred, the head was repositioned first, and then the rate of supplemental oxygen was increased. Firstly, verbal and stimulation were used to trigger breathing, then supplemental oxygen was given via nasal cannula 4-6 l/min. If SpO2 decreased and manevuers were not helpfull, the patients received 4 to 6 l/min of oxygen via nasal cannula or 6 – 10 l/min of oxygen via face mask. All patients were monitored until their SpO2 levels were completely normal and they did not require supplemental oxygen.

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A six - point sedation scale (modified Ramsay scale) was used to evaluate depth of sedation. 1 point - anxious, agitated and/or restless, 2 point - cooperative, orientated, quite patient, 3 point – asleep, brisk response to loud auditory stimulus, 4 point – asleep, sluggish response to loud auditory stimulus, 5 point – no response to loud auditory stimulus, but response to painful stimulus, 6 point – no response to painful stimulus.

A five – point scale was used for satisfaction scale. Patients satisfaction intra-operative experience were assessed after 2 hours after operation.

Descriptive statistics used for statistics quantitative data: frequences and average values were analyzed. For statistical analysis of this study, the non-parametric method was used due to the small sample size. The Mann–Whitney U test was used to compare the two groups of drugs.

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5. RESEARCH RESULTS

5.1. Patients characteristics

Sixty – five patients were screened for eligibility. Four patients were excluded from the analysis when regional anaesthesia converted in general (Figure 5.1.1.). Thirdy – one patients in the group P and thirdy patients in the group M completed the protocol, and their data were analysed.

Figure 5.1.1. Study flow diagram

The two groups were homogeneous according to demographic data (patient age, gender). The were no significant differences regional anaesthesia method (periferal regional block and spinal anaesthesia) between two groups (Table 5.1.1).

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Table 5.1.1. Patients’ characteristics

Characteristics Group P Group M p value

Gender Female 14 (48.3%) 15 (51.7%) ns Male 17 (53.1%) 15 (46.9%) ns Age (y) 59 (36–80) 57 (38–76) ns Anaesthesia Spinal anaesthesia 16 (53.3%) 14 (46.7%) ns

Peripheral regional block 15 (48.4%) 16 (51.6%) ns

ns not significant

5.2. The comparison sedation effects between midazolam and propofol

Ramsay sedation scale scores were measured and recorded in 15-minute intervals throughout the procedure and at discharge; they are shown in Table 2. Mean sedation scores of patients in Group P receiving propofol were significantly higher than those of patients in Group M receiving midazolam (P = 0.001).

Table 5.2.1. Mean Ramsay Sedation scores

Mean Ramsay Sedation Scale Score Mean Score ±SD Group P

Mean Score ±SD Group M

Before start the anaesthesia 1.3±0.54 1.5±0.49

On initiation operation 5.09±0.56 4.83±0.68 At 15th minute 4.06±0.41* 3.77±0.54* At 30th minute 3.79±0.46* 3.21±0.39* At 45th minute 4.08±0.55* 3.50±0.52* At 60th minute 4.06±0.35 4.02±0.38 At 90 th minute 4.55±0.62* 4.10±0.59* At discharge 4.21±0.45 4.18±0.42

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5.3. The comparison haemodinamics parameters between midazolam group

and propofol group

Patients in both groups experienced a significant decrease in arterial systolic blood pressure during sedation (group P p=0.0018) and group M p=0.0032) for both groups, although the difference between groups was not significant (p=0.105).

Table 5.3.1. Haemodinamical changes in groups: systolic arterial blood pressure

Systolic arterial blood pressure Mean Score ±SD Group P

Mean Score ±SD Group M

Before start the anaesthesia 135±13 139±14

On initiation operation 102±15** 104±16** At 15th minute 114±14* 118±15* At 30th minute 108±14** 111±16* At 45th minute 112±15* 115±12* At 60th minute 108±16** 112±14* At 90 th minute 115±10* 127±19 At discharge 128±14 132±14

Value are means±SD, *p<0.01 and **p<0.05, relative to baseline (before start the anaesthesia)

Both groups showed comparable diastolic blood pressure decreases in during sedation, although the difference between groups was not significant (p=0.81).

Table 5.3.2. Haemodinamical changes in groups: diastolic arterial blood pressure

Diastolic arterial blood pressure Mean Score ±SD Group P

Mean Score ±SD Group M

Before start the anaesthesia 81±13 85±14

On initiation operation 63±8** 68±10** At 15th minute 72±10* 72±15* At 30th minute 62±14** 79±9* At 45th minute 76±9* 78±12* At 60th minute 70±11** 79±11* At 90 th minute 74±10* 72±10* At discharge 69±8* 82±14

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Baseline heart rate (HR) and blood pressure (BP) were comparable in the propofol and midazolam groups (Table 5.3.3.), but a statistically significant difference in heart rate (HR) was noted during sedation and the recovery period. Both groups showed comparable decreases in blood pressure during sedation. During the recovery period, blood pressur returned to baseline with midazolam but remained below baseline with propofol.

Table 5.3.3. Heart rate, arterial blood pressure changes between groups in specific times

periods

*P < 0.05 between propofol and midazolam groups

5.4. The comparison the incidence of respiratory depression between

midazolam and propofol group

During the sedation period, the RR (breaths/min) was 16±2 in the propofol group and 16 ±3 in the midazolam group (Figure 5.4.1.).

Oxygen saturation as measured by pulse oximetry deceased to < 95% but still >90% in 9 patients (28%) in group P and 7 (24%) in group M (p=0.62). Firstly, verbal and stimulation were used to trigger breathing, then supplemental oxygen was given via nasal cannula 4-6 l/min. The most serious hypoxia with low SpO2 levels <90% was noted in 6 (19.3%) and 3 (10.3%) in groups P and groups M, respectively (p=0.311). Suplement oxygen was given via face mask and airway opening maneuvers performed in 5 patients. Positive pressure ventilation was necessary in only 1

Baseline Sedation At discharge

Group P (propofol)

Heart rate (bpm) 75±5 73±5 65±5*

Systolic blood pressure (mmHg) 131±13 104±10 113±11

Diastolic blood pressure (mmHg) 81±10 63±8 67±8

Mean arterial blood pressure (mmHg)

99±13 75±7 82±8

Group M (midazolam)

Heart rate (bpm) 74±5 82±7* 74±6

Systolic blood pressure (mmHg) 126±16 112±14 119±13

Diastolic blood pressure (mmHg) 75±11 67±9 72±12

Mean arterial blood pressure (mmHg)

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patients in group P.

Figure 5.4.1. Respiratory rate

5.5. Satisfaction score of sedation

A five – point scale was used for satisfaction scale. Patients satisfaction intra-operative experience were assessed after 2 hours after operation.

Our study results show, that the patients’s satisfaction score were high during intra-operative period in both group. There was not different in two groups (mean satisfaction score in group P 4.62±0.35 and group M 4.52±0.36, p=0.85).

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Figure 5.5.1. Satisfaction score

Our data showed a statistically significant correlation between the mean sedation score and satisfaction score. A deeper sedation improving patient satisfaction. Higher satisfaction score levels were associated with deeper sedation level during the intra – operative period (Figure 5.5.2.).

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6. DISCUSION OF THE RESULTS

Procedural sedation and analgesia is an intermediary state between general anesthesia and consciousness that is created and maintained when anesthetic agents are administered in lower doses than are necessary in general anesthesia. This level of consciousness is preferred over anaesthesia in many procedures, especially when short recovery periods are desired This study compared the efficacy and adverse effect potentials of propofol and midazolam during regional anaesthesia. Both drugs have been preferred over others because of their high potency, short half-lives, and low potential of adverse effects.

We found than mean sedation scores of patients receiving propofol were significantly higher than those of patients receiving midazolam (Table 5.2.1.). The same was confirmed by Laijmer H., et al. in study 2016 [47] and Sebe A., et al in study [48]. This is especially important in those cases, when the procedure is done without analgesia or regional anaesthesia. Exactly deeper sedation lets various diagnostical (endoscopy, bronchoscopy) or minimally invasive curative procedures (punctures in ultrasound control to be done in more comfortable conditions.

It is needed to mark that we used bigger dose of midazolam (0.2 mg/kg - 2 to 3 mg/kg IV in an adult max 5 mg IV) during our research that in studies of other authors (0.05 – 0.1 mg/kg; 0.03 – 0.2 mg/kg/h infusion). Sebe A. et al., Jevdjic et al. and Lameijer H et al. states that midazolam does not always cause more effective sedation [47, 48, 49]. All authors indicate that clinically adequate moderate IV sedation with midazolam should always be achieved through slow titration. This significant superiority of propofol is expected because of its high potency and other pharmacologic effects. Reyle-Hahn et al [50] and Havel et al [51] reported similar findings. However, in the present study, mean sedation scores obtained to estimate clinical levels of sedation were significantly lower in Group P than in Group M (P = 0.001). Havel et al [51] reported more favorable mean sedation scores among patients treated with propofol than in those treated with midazolam, although the study was too limited in size to extrapolate the results.

Heart rate (HR) and arterial blood pressure (BP) changes have been reported during conscious sedation with propofol and midazolam. One potential mechanism to explain these changes is that propofol and midazolam affect HR and BP via changes in the cardiac autonomic nervous system: 1) propofol induces predominance of parasympathetic activity, leading to decreasedHRand BP, and 2) midazolam induces predominance of sympathetic activity, leading to increased HR and decreased BP [52]. Both systolic and diastolic bood pressure readings decreased after the 10th minute and started to normalize to initial levels after the 90th minute. This finding can be considered expected effects of the drugs. Group P showed a greater reduction in systolic blood pressure than Group M, although the difference is not statistically significant (p = 0.15). However,

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diastolic blood pressures decreased significantly more in patients administered propofol (p = 0.0018). Although hypotension is a well-known untoward effect of propofol, the reduction in blood pressure readings in the present study is not in the context of hypotension. Both patient groups experienced a slight decrease in HRs after the tenth minute from drug administration, but this reduction did not have clinical or statistical significance (p = 0.060). The same results demonstraded Sebe A. et al. in study 2014 [48].

The results of our study demonstrated that IV conscious sedations with propofol and midazolam differed in terms of changes in HR during the sedation and recovery periods. During the sedation period, midazolam caused a significant increase in HR and no change in suggesting decreased parasympathetic activity and unchanged sympathetic activity. The increase in HR with decrease in BP during sedation means that baroreflex activity is compensated. However, there has been controversy as to whether midazolam attenuates or compensates the negative feedback mechanism in the regulation of HR by baroreflex activity [52]. Ni Ni Win et al demonstrated a vagolytic effect of midazolam (0.1 -0.2 mg/kg) that caused a increase in HR and decresead BP, and our findings are consistent with theirs (HR in group M baseline 74±5 vs sedation 82±7 and BP baseline 123±16 vs 112±14) [52].

During the sedation period, the RR (breaths/min) was 16±2 in the propofol group and 16 ±3 in the midazolam group. The difference in RR reductions between the groups were not statistically significant (P = 0.333). Peripheral arterial oxygen saturations fluctuated between 97% and 98% from admission to discharge. Oxygen saturation as measured by pulse oximetry deceased to < 95% but still >90% in 9 patients (28%) in group P and 7 (24%) in group M (p=0.62). In the studys of Sebe A et al. [48] and Havel et al [51] of pediatric procedural sedation using propofol and midazolam, reported hypoxemia in 4 - 11.6% in patients receiving propofol and 2 - 10.9% in those receiving midazolam. Although the hypoxemic episodes were temporary and easily relieved with simple, noninvasive maneuvers (P = 1.00).

Firstly, verbal and stimulation were used to trigger breathing, then supplemental oxygen was given via nasal cannula 4-6 l/min. The most serious hypoxia with low SpO2 levels <90% was noted in 6 (19.3%) and 3 (10.3%) in groups P and groups M, respectively (p=0.311). Suplement oxygen was given via face mask and airway opening maneuvers performed in 5 patients. Positive pressure ventilation was necessary in only 1 patients in group P. The events of breathing are described in every study, in which propofol and midazolam sedation was being compared. The cases that were registered in our research, when manual maneuvers and verbal stimulus were needed comply with frequency, published in researches of other authors. All of those events demonstrate that sedated patients must be monitored all the time, all the tools to provide help like oxygen, facial mask, nasal caniulles, equipment for intubation should be ready all the time. If midazolam is allocated for

33 sedation, it is recommended to have antidote flumanzenil for critical caseswhich is the minimum dose accepted for sedation. The initial loading dose of midazolam, however, failed to induce effective sedation in a substantial number of patients, necessitating additional doses (ie, 0.08 mg/kg in 3 of every 5 minutes titrated to effect).

Patient satisfaction is an important outcomes measurement as a result, in part, of its influence on the delivery of medical care at both the societal (total consumption of health care resources) and individual (patient participation) level [2]. Regional anaesthesia and analgesia have been shown to improve clinically oriented outcomes, and many studies investigating the use of regional anaesthesia and analgesia have incorporated patient satisfaction measurements. The effect and determinants of regional anaesthesia and analgesia on patient satisfaction are not well established, despite the potential benefits of regional anaesthesia and analgesia [45]. Our study demonstrated that patient‘s satisfaction score was high. The patients’s satisfaction was not different in two groups (mean satisfaction score in group P 4.62±0.35 and group M 4.52±0.36, p=0.85). Alhashemi AJ in study demonstrated that comparison midazolam and dexmedetomidine does not appear to be suitable for sedation in patients undergoing surgery [53]. However, several other studies demonstrate the positive influence of sedation on reduction of patients’ anxiety and improvement of patients’ satisfaction during [54]. Sedation may improve safety and success of peripheral nerve block placement. The objective of study Kubulus Ch et al) was to evaluate complications related to central and peripheral regional block and patient satisfaction in awake, sedated and anaesthetised adult patientA deeper sedation improving patient satisfaction. Our data showed a statistically significant correlation between the mean sedation score and satisfaction score (r=0.521, p<0.001).

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7. Conclusion

1. The results of study shows that the sedation level was higher in propofol group.

2. The difference in haemodynamical events between the propofol and midazolam groups were not significant.

3. The difference in respiratory events between the propofol and midazolam groups were not significant.

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8. Practical recommendation

1. Continuous sedation will help to increase comfort, especially during long surgery or uncomfortable positioning. But the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Practitioners providing procedural sedation should have a thorough knowledge of the pharmacology of the agents used.

2. Adverse events during procedural sedation may be prevented by the appropriate pre-sedation evaluation of the patient, intraprocedural monitoring of physiologic function, and early intervention when adverse effects are recognized.

3. The role of nurses during sedation:

 Understand levels of procedural sedation;

 Know who can administer sedation;

 Know what OUR responsibilities are;

 Responsibilities in the procedure room;

 Know the properties of the medications given for sedation;

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LIST OF SCIENTIFIC REPORTS PUBLICATION

Stebymol Thomas, Laima Juozapaviciene. Monitoring consciousness during period of sedation. 2019 – Nurses: Avoice to lead – health for all, Kaunas.