بررسی بیخطری و كارايي انفوزیون دوز پایین پروپوفول در مقایسه با میدازولام، طی اعمال کولونوسکوپی و کلانژیوپانکراتوگرافی رتروگراد

Abstract

Introduction: Propofol can be used for intravenous sedation in gastrointestinal endoscopic procedures but a safe and effective dose for outside operating room usage is not defined. In this single blind clinical trial we compare safety and efficacy of low dose intravenous propofol sedation (0.8mg/kg stat and 25µg/kg/min maintenance) with intravenous midazolam sedation (0.1mg/kg). Method: During a 7 month period of this clinical trial, 140 consecutive patients undergoing routine colonoscopy and ERCP randomly received either midazolam or propofol for sedation. Vital signs (systolic blood pressure, heart rate, respiratory rate and SPO2) were continuously monitored for safety measurement and procedure related variables, patient's autonomic and somatic response to stimulus, the recovery time and postanesthesia discharge time, patient’s intraoperative awareness and gastroenterologist satisfaction were assessed for efficacy measurement of two methods. Results: In propofol group mean systolic blood pressure changes (initial systolic blood pressure vs. maximum systolic blood pressure during procedure) was less than midazolam group (P<0.05). Mean respiratory change (initial respiratory rate vs. minimum heart rate during procedure and initial SPO2 with room air vs. minimum SPO2 during procedure with 5 lit/min O2) had no differences in two groups. Apnea and hypoxia was not observed in any patient. Mean recovery time and mean postanesthesia discharge time were significantly lower in propofol than midazolam group. Other variables had no significant differences in midazolam and propofol group. Conclusions: Low dose propofol sedation (0.8mg/kg stat and 25µg/kg/min maintenance) is safer and more effective than midazolam (0.1 mg/kg) sedation and is associated with less systolic blood pressure changes, faster recovery and shorter postanesthesia discharge time.