Yoshitaka Fujii1, Aki Uemura, Hiroyoshi Tanaka. 1. Department of Anaesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba City, Ibaraki, Japan. yfujii@md.tsukuba.ac.jp
Abstract
OBJECTIVE: To evaluate the efficacy and safety of ramosetron (a 5-hydroxytryptamine type 3 receptor antagonist) for the prevention of nausea and vomitingafter laparoscopic cholecystectomy. DESIGN: Prospective, randomised, double-blind, placebo-controlled study. SETTING:University and university-affiliated hospitals, Japan. SUBJECTS:100 patients, 65 women and 35 men, who had laparoscopic cholecystectomy. INTERVENTIONS: Patients were given either placebo or ramosetron at 3 different doses (0.15 mg, 0.3 mg, 0.6 mg) intravenously at the completion of operation. The general anaesthetic technique and postoperative analgesia were standard. MAIN OUTCOME MEASURES: Vomiting and safety were assessed for 0 to 24 hours and 24 to 48 hours after anaesthesia. RESULTS: The number of patients who had a complete response (no nausea, no retching, no vomiting) during 0 to 24 hours after anaesthesia was 15/25 with placebo, 17/25 with ramosetron 0.15 mg, 23/25 with ramosetron 0.3 mg, and 23/25 with ramosetron 0.6 mg; The corresponding numbers from 24 to 48 hours were 16, 17, 23, and 23. No serious adverse events were observed in any of the groups. CONCLUSIONS:Ramosetron 0.3 mg was the minimum effective dose for preventing postoperative nausea and vomiting during 0 to 48 hours after anaesthesia in patients undergoing laparoscopic cholecystectomy.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of ramosetron (a 5-hydroxytryptamine type 3 receptor antagonist) for the prevention of nausea and vomiting after laparoscopic cholecystectomy. DESIGN: Prospective, randomised, double-blind, placebo-controlled study. SETTING: University and university-affiliated hospitals, Japan. SUBJECTS: 100 patients, 65 women and 35 men, who had laparoscopic cholecystectomy. INTERVENTIONS:Patients were given either placebo or ramosetron at 3 different doses (0.15 mg, 0.3 mg, 0.6 mg) intravenously at the completion of operation. The general anaesthetic technique and postoperative analgesia were standard. MAIN OUTCOME MEASURES: Vomiting and safety were assessed for 0 to 24 hours and 24 to 48 hours after anaesthesia. RESULTS: The number of patients who had a complete response (no nausea, no retching, no vomiting) during 0 to 24 hours after anaesthesia was 15/25 with placebo, 17/25 with ramosetron 0.15 mg, 23/25 with ramosetron 0.3 mg, and 23/25 with ramosetron 0.6 mg; The corresponding numbers from 24 to 48 hours were 16, 17, 23, and 23. No serious adverse events were observed in any of the groups. CONCLUSIONS:Ramosetron 0.3 mg was the minimum effective dose for preventing postoperative nausea and vomiting during 0 to 48 hours after anaesthesia in patients undergoing laparoscopic cholecystectomy.
Authors: Jae Young Ji; Nan Seol Kim; Yong Han Seo; Ho Soon Jung; Hea Rim Chun; Jin Soo Park; Jeong Soo Choi; Jae Min Ahn; Woo Jong Kim Journal: Medicine (Baltimore) Date: 2022-09-02 Impact factor: 1.817