Conscious Sedation in Spinal Anesthesia: a Comparative Study of Propofol Versus Midazolam

ORIGINAL ARTICLE

CONSCIOUS SEDATION IN SPINAL 1 Consultant Anesthetist, Combined Military Hospital (CMH) Rawalpindi, Pakistan Email: [email protected] 2 Anaesthesia Registrar, CMH Rawalpin- ANESTHESIA: A COMPARATIVE STUDY di, Pakistan 3 Consultant Anaesthetist, CMH Rawal- OF PROPOFOL VERSUS MIDAZOLAM pindi, Pakistan Date submitted: November 04, 2015 Date last revised: March 20, 2017 Asjad Sharif1, Syed Ehtesham Haider Naqvi2, Amanat Khan3 Date accepted: March 21, 2017 when there is onset of slurred speech. It avoids the adverse psychological and ABSTRACT physiological effects of stress. It reduces OBJECTIVE: To determine the advantages of conscious sedation in spinal anxiety in frightened and agitated pa- anesthesia by comparing Propofol with Midazolam. tients. It provides anterograde amnesia METHODS: The study was carried out on 60 patients undergoing various especially after Midazolam and patient is elective surgical procedures under spinal anesthesia. The patients were not troubled with unpleasant and fright- divided into three groups each containing 20 patients. Group A (n=20) ening memories of their surgical proce- received initial bolus of 30 mg of Propofol intravenously (IV) followed by 10 mg top ups on as-required basis. Group B (n=20) received initial dure. Conscious sedation is being widely bolus of 2 mg of Midazolam followed by 1 mg increments to maintain used in various diagnostic,3,4 surgical and the conscious sedation. Group C (n=20) did not receive any conscious therapeutic procedures. Its use in spinal sedation (Control). The patients were interviewed through a structured anesthesia is becoming increasingly popu- questionnaire before anesthesia and 24 hours after the surgical proce- lar.5 The goals and objectives of conscious dure. Demographic variables were scored using descriptive statistics and results were analyzed using correlation methods. sedation are to provide a tranquil patient, RESULTS: It was revealed that in patients who were given conscious free from anxiety with reduced attention, sedation, 17 patients (85%) from Midazolam group as compared to 12 amnesia and retention of verbal commu- patients (60%) from Propofol group were not willing to have remained nication and cooperation albeit sluggish.6 wide awake during the procedure. Similarly 15 patients (75%) from It provides calming effect and minimizes Midazolam group as compared to 10 patients (50%) from Propofol group stress. Despite the established record7 of were very much comfortable being asleep during the procedure. Te n patients (50%) from the group who were not given conscious sedation safety of conscious sedation, problems remained apprehensive and uncomfortable and they very much desired have occurred as one degree of seda- to be sedated during the procedure. tion may progress to another depending CONCLUSION: Conscious sedation was very effective in spinal anes- upon the dose of the administered drug. thesia in alleviating preoperative anxiety and apprehension. Midazolam These include hypoventilation, apnoea, proved to be a better agent than Propofol for the purpose. airway obstruction and cardiopulmonary KEY WORDS: Conscious sedation (MeSH), Spinal anesthesia (MeSH), impairment. Appropriate agents provide Propofol (MeSH), Midazolam (MeSH). safe and effective sedation and ensure greatest margin of safety. Conscious THIS ARTICLE MAY BE CITED AS: Sharif A, Naqvi SEH, Khan A. Con- sedation may be produced by adminis- scious sedation in spinal anesthesia: A comparative study of Propofol tration of various pharmacological agents versus Midazolam. Khyber Med Univ J 2017; 9(1): 15-18. by several common routes.8-11 In this study intravenous route is adopted and Propofol is compared with Midazolam to determine the advantages of conscious Consciousness is defined as a state of INTRODUCTION sedation in spinal anesthesia. awareness of surroundings and alert- onscious sedation is the use of ness to events.2 Sedation describes a Cmedication to minimally depress the METHODS level of consciousness in a patient while depressed level of consciousness which It was an observational analytical study allowing the patient to continually and in- may vary from light to deep. Conscious dependently maintain a patent airway and sedation is a controlled state of pharma- in which effects of conscious sedation in respond appropriately to gentle physical cological depression of consciousness spinal anesthesia was observed and ana- stimulation or verbal communication, e.g. enabling treatment to be carried out and lyzed by using two different drugs for this “open your eyes”. communication is maintained throughout purpose, i-e Propofol versus Midazolam. Patient arrives and leaves in a con- the period of sedation besides maintain- The study was initiated after taking ap- dition as close to normal as possible.1 ing protective reflexes. It is achieved proval from hospital ethical committee.

KMUJ 2017, Vol. 9 No. 1 15 Conscious sedation in spinal anesthesia: A comparative study of propofol versus midazolam

The study was carried out in 60 pa- litre of Ringers lactate and given 10 mg variables were computed, data was an- tients, above 20 years of age (majority of injection Maxolon IV. A local infiltration alyzed using statistical package for social between 40 and 50 years of age) having of 2 ml of 1% plain Lignocaine was given sciences (SPSS) version 17. physical status of American Society of and spinal anesthesia was administered Anesthesiologists (ASA) i.e. ASA–I (A in lying position with 25 gauge spinal RESULTS normal healthy patient) and ASA–II (A needle using 2 ml of 0.75% hyperbaric This study gave us some very inter- patient with mild systemic disease). Bupivacaine in each case. Non invasive esting results and quite a few important Both male and female cases (male-42 blood pressures, O saturations and 2 observations. It was revealed that in and female-18) were randomly select- ECGs were monitored throughout patients who were given conscious ed. The cases who were administered the procedure. A questionnaire was sedation, 17 patients (85%) from spinal anesthesia were restricted to completed for each patient. In this the lower abdominal, orthopaedic and comments and responses of the patient Midazolam group as compared to 12 perineal elective surgical procedures at the time of preanesthetic assessment patients (60%) from Propofol group (Table I) were documented followed by another were not willing to have remained wide awake during the procedure. Similarly The patients were divided into three question – answer session 24 hours after groups which were: the surgical procedure. Patients with 15 patients (75%) from Midazolam extremes of ages, having psychological group as compared to 10 patients Group A (n=20) Patients who were / emotional disturbances, those who did (50%) from Propofol group were administered Propofol for conscious not have dense spinal block, and those very much comfortable being asleep sedation. who developed significant hypotension during the procedure. Ten patients Group B (n=20) Patients who were and incidence of vomiting were excluded (50%) from the group who were not administered Midazolam for conscious from the study. given conscious sedation remained sedation. Descriptive statistics were used to apprehensive and uncomfortable and Group C (n=20) This group did not describe the data. Moreover, frequen- they desired to be sedated during the receive any conscious sedation and was cies and percentages of demographic procedure (Table II, III and IV). treated as a control group. In group A, the patients were given TABLE I: VARIETY OF SURGICAL PROCEDURES Lignocaine 40 mg IV before Propofol Indications Frequency Percentage to avoid pain on injection. Subsequently an initial bolus of 30 mg Propofol was Hernia / Hydrocele 15 25 administered IV followed by 10 mg top Orthopaedic Surgery 07 11.7 ups on as-required basis. Apppendicectomy 10 16.7 In group B, the patients were given Ovarian Tumours and Mass 03 5 an initial bolus of 2 mg of Midazolam Tubal ligation 05 8.3 followed by 1 mg increments to maintain Vaginal hysterectomy 05 8.3 the conscious sedation. The end point of Perineal Surgery 15 25 conscious sedation in both groups A and Total 60 100 B was the slurring of speech, preserva- tion of eye opening response to verbal TABLE II: GROUP A: PATIENTS GIVEN CONSCIOUS SEDATION command being sedated at the same WITH PROPOFOL (n=20) time. Very much Slightly No Absolute calm and tranquility was ensured throughout the surgical proce- Fre- % Fre- % Fre- % quency age quency age quency age dure. All the patients were reassured and briefed about the procedure of spinal an- 1 Were you comfortable 10 50 06 30 04 20 esthesia and surgery. The patients were being asleep during procedure? clearly informed whether they were going to be sedated or would remain 2 Do you wish that it 02 10 06 30 12 60 would have been better wide awake during the procedure. All if you had remained wide the patients were preloaded with one awake during procedure?

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TABLE III: GROUP B: PATIENTS GIVEN CONSCIOUS SEDATION Propofol is associated with a more WITH MIDAZOLAM (n=20) rapid onset of sedation and quick recovery than Midazolam. Midazolam, Very much Slightly No however is associated with a higher Fre- % Fre- % Fre- % degree of amnesia, low incidence of quency age quency age quency age venous complications and better patient 1 Were you comfortable 15 75 03 15 02 10 acceptability than Propofol.16 According being asleep during pro- to the study by Grendelmeier P the cedure? advantages of Propofol over Midazolam 2 Do you wish that it 0 0 03 15 17 85 were the ease with which the degree would have been better if you had remained wide of sedation could be altered and quick awake during procedure? recovery.17 Its disadvantages were pain on injection, increased talkativeness, the TABLE IV: GROUP C: PATIENTS NOT GIVEN ANY CONSCIOUS extra equipment needed and the cost. SEDATION (n=20) These results are also in agreement with 17 Very much Slightly No our study. A study by Lordan JT again concluded that continuous infusion of Fre- % Fre- % Fre- % quency age quency age quency age Propofol and Midazolam for sedation in regional anaesthesia were equivalent 1 Were you comfortable 10 50 02 10 08 40 18 being asleep during pro- with respect to efficacy and safety. cedure? According to another study both drugs were equally effective sedative agents.19 2 Do you wish that it 10 50 02 10 08 40 would have been better While going through the above men- if you had remained wide tioned studies it is evident that results awake during procedure? of our study are in agreement with majority of the investigations but also DISCUSSION ed recovery, patient is up and about early, differ from quite a few. The reason for has got an antiemetic effect but the use During surgery under spinal anes- these differences in results may partially of Propofol was quite taxing because top thesia unpleasant sensory sensations be attributed to the dose and technique up doses were required at frequent inter- occur as afferent sensory supply to gut of administration. In addition, medica- vals. One has to be very vigilant and alert is not blocked. Vagal afferent is also not tion requirements20 may be affected by regarding cardiovascular stability, respira- blocked and severe discomfort occurs various pharmacodynamic and pharma- tory depression due to lower therapeutic while manipulating abdominal structures. cogenetic differences among individuals. index.12 It also required controlled cir- Sedation besides relieving the above Clinically relevant factors including con- cumstances as compared to Midazolam. mentioned problems provides additional comitant medication, age, ASA physical A study conducted by Elvir Lazao OL13 relief from anxiety and apprehension. status and drug interaction can alter also confirms the leading position of Mid- Similarly listening to noises of cutting drug’s pharmacokinetic properties and azolam in conscious sedation, anesthesia instruments is very disturbing for the influence the outcome of results. and intensive care. Similar results were patient and he is relieved of this agony achieved in another study carried out by by conscious sedation. Calm and quite CONCLUSION Bagchi D14 and coworkers when Propofol atmosphere must prevail at all times Conscious sedation not only helped sedation for outpatient gastrointestinal in operation theatre. Communication in smooth administration of spinal and endoscopy was compared with Midazol- and reassurance have been shown to with no degree of apprehension but am in 40 patients. It was concluded that decrease anxiety, stressful environmental also produced conducive circumstances although Propofol provided more rapid factors like noise, proximity of other for surgical procedure itself. Midazolam recovery as compared to Midazolam but seriously ill or the unconscious patients. proved to be a better agent than Propofol also associated with pain on injection, a Our study shows that Midazolam has for conscious sedation. short amnesic span and reduced patient better sedative and amnesic effects, acceptance.13 In another study it was with no pain during administration, and REFERENCES shown that Midazolam was better at better cardiovascular stability. Although 1. Kroczak TJ, Kaler KS, Patel P, Al-Essawi T. providing amnesia than Propofol at the Propofol sedation ends up in clear head- Ureteroscopy with conscious sedation for same level of sedation.15 distal ureteric calculi: 10-year experience.

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AUTHORS’ CONTRIBUTION Following authors have made substantial contributions to the manuscript as under: AS: Concept & study design, acquisition analysis and interpretation of data, drafting the manuscript, final approval of the version to be published SEHN: Acquisition of data, drafting the manuscript, final approval of the version to be published AK: Acquisition of data, drafting the manuscript, critical revision, final approval of the version to be published Authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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