Propofol is a new, rapidly effective, short-acting intravenous sedative-hypnotic agent that can be used for induction and maintenance of general anesthesia. This study was performed to evaluate the efficacy and safety of domestic product PofolR
in
comparison with DiprivanR for the management of total intravenous general anesthesia by double blind method.
This study was approved by the Clinical Research Committee of SNUH. Test drugs were administered in a double-blinded fashion for the anesthesia. Seventy-four patients(aged 18-60 yr, operation time below two hours) were induced anesthesia with
bolus
injection of 2 mg/kg of test drug for 20 seconds and then anesthesia was maintained with continuous infusion method by syringe pump. Infusion dose of test drug during maintenance of anesthesia was controlled to maintain the systolic blood
pressure
measured at ward ±20%. To evaluate the efficacy of drug, induction dose, mean maintenance dose, time to loss of conciousness after injection of induction dose and awakening time were measured or calculated. To evaluate the safety of drug, pain
after
injection of drug, recovery condition of patients and adverse events or side effects were recorded. Changes of blood pressure and heart rate were measured and arterial blood gas was also analyzed during perianesthetic period.
There were no statistically significant differences in sex, age, weight, duration of anesthesia and ASA physical status distribution between Pofol Group(P) and Diprivan group(D). There were no differences in induction dose and mean maintenance
dose
between P and D (mean±SD, 121±25 mg and 0.213±0.064 mg/kg/min vs 125±27 mg and 0.233±0.058 mg/kg/min, respectively). Time to loss of conciousness, time to response and time to orientation after cessation of drug were 14±19 sec, 10 min 2
sec±5 min
39 sec, 17 min 16 sec±9 min 43 sec for P and 14±26 sec, 12 min 52 sec±8 min 42 sec, 22 min 47 sec±14 min 17 sec for D. But there were no statistically differences between P and D, respectively. The incidence of pain after injection was 65.7%
for P
and 52.7% for D. Recovery from anesthesia was assessed as smooth in 82.9% for P and 91.7% for D. Adverse events during induction were recorded in four patients (apnea(1), opisthotonus(2) and hypotension(1)) for P and in two patients (apnea(1),
bradycardia(1)) for D. The number of patients showed adverse events during maintenance of anesthesia and postanesthesia recovery period were same to P and D as 8 patients. Even though the characters. Of adverse events to P and D were different,
the
incidence rate was not different between two drugs. These adverse events were resolved without any specific treatment.
In conclusion, there were no differences in efficacy in efficacy and safety between Pofol and Diprivan.
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