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Pofol and Thiopentone As Induction Agents in Outpatient Surgery

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Pofol and Thiopentone As Induction Agents in Outpatient Surgery It0 A comparison of pro- pofol and thiopentone as induction agents in Gerald Edelist Mo FRCP outpatient surgery We studied 90 healthy ASA physical status I or I1 female Diisopropylphenol (propofol) is an induction agent which patients s for outpatient therapeutic abortions. Sixty has been studied in Europe but only recently has become patients received induction doses of propofol (2.5 rag" kg -j) available for clinical trials in North America. Since pro- and 30 patients received thiopemone (4 rag. ~g - t t. Anaesthesia pofol is not water soluble, its original formulation involved was maintained with nitrous oxide plus additional doses of the solution in cremophor-EL, Induction with this formula- agent used for induction. Comparisons were made regarding tion was unacceptable because of the high incidence of the efficacy of induction and maintenance, rapidity of recover, allergic phenomena to the cremophor base. Recently an haemodynamic and respiratory variables and side effects, aqueous emulsion of propofol has been produced which The number of "excellent" inductions was sigt*ificantly dif- should avoid the problems attributed to cremophor. This ferent (p = 0.02), with 97 per cent of the patients induced with milky emulsion has made it difficult to blind the observer propofol and 80 per cent of the patients induced with thiopen- to which drug is being used and to date no previous study tone receiving this rating. A larger number of patients receiv- has made an attempt to solve this problem. This study ing propofol exhibited minor extraneous muscular movement attempts to do so. As well, we have induced and main- daring induction (p = 0.0I). Recovery for the propofol group tained anaesthesia with the study drugs in unpremedicated was significantly more rapid than with the thiopentone group outpatients using only nitrous oxide supplementation. (p = 0.001). The respiratory effect of the two drugs was not This allowed us to evaluate the safety and efficacy of significantly different. Propofal caused a decrease in pulse rate propofol and compare it to thiopentone as an induction and a decrease in systolic, diastolic and mean pressure which and maintenance agent for short outpatient procedures were significantly greater than with thiopentone. without further supplementation. From the observations made we conclude that propofol has the potential to be an excellent induction and maintenance agent for outpatient surgery in combination with nitrous oxide Methods alone. With approval from the Human Subjects Review Com- mittee at the University of Toronto, informed consent was obtained from 90 healthy female patients. The patients were ASA physical status I or II, between 18 and 40 years of age and scheduled for therapeutic abortions in the first trimester of pregnancy. The patients were ran- domly assigned to receive either propofol or thiopentonc with 60 patients receiving propofol and 30 receiving thiopentone. This numerical imbalance was deliberate and designed to increase our experience with the new drug without prolonging the study or decreasing its statis- tical power. We excluded those patients with a history of allergy to the trial drugs and those who had had an ad- Key words verse anaesthetic reaction of any kind. We also excluded ANAESTHESIA: outpatient; ANAESFHETICS INTRAVENOUS: morbidly obese patients (30 per cent above ideal weight) propofol, thiopentonc. and those who could not communicate effectively with the investigator. All anaesthetics were administered by From the Department of Anaesthesia, Mount Sinai Hospital, the author and all observations during anaesthesia and 600 University Avenue, Toronto, Ontario, MSG 1XS. recovery were made and recorded by a research assistant CAN J ANAESTH 1987 l 34:2 / pp 110-6 Edelist: PROPOPOL FOR OUTPATIENT SURGERY 111 who was unaware of which drug had been administered. operative period, beginning with the termination of N20, Since propofol in aqueous emulsion is a milky substance the time to opening of the eyes, response to verbal which is easily distinguished from thiopentone, all syrin- command and orientation were noted. Post Anaesthesia ges were taped to prevent the observer from seeing their Recovery Scores (PARR) I were measured every five contents. A small window in the tape was left so the minutes for the first 20 minutes and then every ten volume of the contents of the syringe could be seen by minutes up to 60 minutes. The PARR score was deter- the anaesthetist and the appropriate dose administered, mined by considering the following factors: motor re- The patients had no knowledge of which drug they had sponse, respiration, blood pressure, consciousness and received until the termination of the study. skin colour. Each factor was scored 0, I or 2 with 0 The non-premeditated patients were placed on the being the "worst" and 2 being the "best" recovery. operating room table and were monitored with a non- The evaluation of induction and maintenance was rated invasive blood pressure ocillometric apparatus (Data- as either excellent, good or poor. The induction was scope),* lead II of the electrocardiogram, precordial considered excellent if the patient fell asleep in the first stethoscope and infrared CO2 analyzer (Beckman). An minute and stayed asleep; good if the patient fell asleep intravenous infusion was begun in an antecubital fossa or in the first minute but required a second dose before the forearm with five per cent dextrose in lactated Ringer's three-minute period had elapsed and poor if the patient solution. Baseline measurements were then recorded of did not fall asleep within one minute or awakened within systolic, diastolic and mean blood pressure, pulse rate, three minutes and did not fall asleep with the second end-tidal PCO2 and respiratory rate. The trial drug (either dose. Maintenance was considered excellent if respiratory 4mg'kg -I of thiopentone or 2.5 mg-kg -I of propofol) and haemodynamic parameters remained within ten per was injected into the intravenous tubing over a period of cent of preoperative values; good if mitt respiratory or 20-30 seconds. The patient was instructed to count back- haemodynamic depression occurred, defined as end-tidal wards from one hundred and was advised to note any PCO2 between 45-55mmHg and blood pressure and feeling at the IV site. Induction time was determined as paise remaining within 30 per cent of preoperative values the time measured by a stop watch until the counting with no ECG dysrhythmias and poor if there was evi- ceased and the patient failed to respond to command. If dence of moderate to severe respiratory or haemodynamic the patient failed to fall asleep within one minute a depression, defined as end-tidal PCOz above 55 mmHg second dose (50 percent of the first) was administered. If and/or blood pressure and pulse rate changes greater than the patient failed to fall asleep within one minute of the 30 per cent of preoperative values and/or ECG dysrhyth- second dose a third dose (50 per cent of the first dose) mias observed. was administered. If the third dose failed to produce Statistical significance (p < 0.05) was based on a sleep the induction was considered a failure. From this two-tailed hypothesis. Overall response to induction and point induction variables of systolic, diastolic and mean maintenance were compared between anaesthetic agents blood pressure, pulse rate, respiratory rate and end-tidal using a Fisher's exact test. Haemodynamie and respira- PCO2 were measured each minute for three minutes tory parameters were compared between drugs using a while the patient breathed 100 per cent 02. At the end of repeated measures analysis of variance. In the presence three minutes the induction was considered to be com- of a significant drug-time interaction, change from base- plete and N20 70 per cent, and O2 30 per cent were line to each of the other protocol time points were exam- administered. Anaesthesia was maintained with intermit- ined using W~lcoxon rank-sum tests. Time to awaken- tent boluses of 50 per cent of the induction dose of the ing, response time to a verbal command and time to test drug in response to clinical signs of light anaesthesia orientation were measured from the time at which all which included movement in response to surgical stim- anaesthetic agents were discontinued. All recovery times uli, tearing, phonation, increases in blood pressure, pulse were compared between drugs using an analysis of vari- rate and respiratory rate or depth. The physiological ance model with duration of anaesthesia as a covariate. variables were recorded each minute during the mainte- Each of the five dimensions of the PARR score were nance period. When the procedure was terminated N20 compared between treatment groups using multivariate was stopped, 100 per cent O2 was delivered for one categorical data modelling techniques as supplied in the minute and recovery was considered to have commenced. CATMOD procedure of SAS. Comparisons between agents All periods of apaoea greater than 30 seconds as well were adjusted for the time from start of the postanaes- as all excitatory movements were recorded. In the post- thefic recovery. Proportions of patients with adverse reactions and excitatory effects were analyzed using a * Datascope Corporation, Paramus, NJ, U S.A. Fisher's exact test. 112 CANADIAN JOURNAL OF ANAESTHESIA TABLE I Summary of induction and maintenanceresults (Mean • SD) Study medication Propofol Thiopenrone (n = 60) (n = 30) Induction of anaesthesia No. of patients induced with dose I 59 28 No. of patients induced with dose 2 1 2 Elapsed time to onset of induction (seconds) 31.9• 32.4" 13,4 Induction dose (rng.kg- ') 249-+0.07 3.98--0.13 Maintenance dose (mg'kg ~'min-j) 0 55" 0.]3 1.07 z0.2l Number of maintenanceboluses* <2 48 8 >2 12 22 *Dis~bution of maintenance boluses significantlydifferent between treatment groups (p < 0.13001).
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