• Anaesthesia · Mar 1993

    Randomized Controlled Trial Multicenter Study Clinical Trial

    The effect of oral ondansetron in the prevention of postoperative nausea and vomiting after major gynaecological surgery performed under general anaesthesia.

    • J P Dupeyron, C Conseiller, M Levarlet, C Hemmingsen, P Schoeffler, F M Pedersen, B Gribomont, and L A Kaplan.
    • Département d'Anesthésie, CHU, Strasbourg, France.
    • Anaesthesia. 1993 Mar 1; 48 (3): 214-8.

    AbstractThe efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following major gynaecological surgery was evaluated in this multicentre, double-blind study. A total of 243 patients were randomised to receive three doses of oral ondansetron 8 mg or matching placebo at 8-hourly intervals, with the first dose being given an hour before surgery. A standard general anaesthetic technique was employed throughout. Nausea, vomiting and safety assessments were performed continuously during the 24 h postrecovery period. Of the 237 patients evaluated for efficacy, significantly fewer ondansetron 8 mg treated patients (65/117; 56%) experienced postoperative nausea and/or vomiting compared with placebo-treated patients (94/120; 78%) during the study period (p < 0.001). In addition, ondansetron 8 mg reduced the severity of nausea (p < 0.001) and the total number of vomiting episodes experienced (p < 0.001). Overall, ondansetron 8 mg was well tolerated and effective in preventing postoperative nausea and vomiting in this surgical setting.

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