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Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial
Yoshitaka Fujii1, Aki Uemura, Hiroyoshi Tanaka
1Department of Anaesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba City, Ibaraki, Japan. yfujii@md.tsukuba.ac.jp
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.
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