A Clinical trial to Compare the effects of sedation with propofol protocol and midazolam and pethidine protocol on endoscopy's side effects in patients referring for endoscopy

This study is Clinical trial to Compare the effects of sedation with propofol protocol and midazolam and pethidine protocol on endoscopy's side effects in patients referring for endoscopy in Ahwaz Imam Khomeini Hospital. The present study is a single-centered double blind randomized controlled trial. The study population includes patients who are referred to Imam Khomeini Hospital in Ahwaz for endoscopy. The main criteria for entering the study are age over 18 years; alertness; ability to participate in gastrointestinal tract endoscopy under sedimentation. The main criteria for exclusion from the study are lack of alertness and sensitivity to anesthetic drugs. The sample size is 266 and the time for intervention is from October to April. In this study, primary and secondary outcomes will be compared in patients undergoing endoscopy under anesthesia with propofol protocol (133 patients) and with midazolam and pethidine protocol (133 patients). Assignment of patients to the study groups will be done by random block method using six blocks. Standardized questionnaire will be used to collect demographic characteristics, laboratory data and clinical information of patients. The initial outcomes of the trial include duration of endoscopy, recovery time after endoscopy, and patient's satisfaction score after awakening and the secondary consequences of the trial include arrhythmia, hypoxia, hypotension, nausea and vomiting. The appropriate statistical tests will be use to compare data between the two intervention groups.

Vice-Chancellor for Research Affairs of Ahvaz Jundishapur University of Medical Sciences.