• Der Anaesthesist · Aug 1998

    Randomized Controlled Trial Multicenter Study Clinical Trial

    [Ondansetron. Prophylaxis and therapy of nausea and vomiting following major gynecologic procedures. Results of a national multicenter study].

    • A Biedler, W Wilhelm, M Silomon, R Awwad, and R Larsen.
    • Klinik für Anaesthesiologie und Intensivmedizin, Universitätskliniken des Saarlandes.
    • Anaesthesist. 1998 Aug 1;47(8):638-43.

    UnlabelledThis investigation was conducted as a national multicenter study to evaluate effectiveness and safety of prophylactic and therapeutic ondansetron for postoperative nausea and vomiting (PONV) in major gynaecological surgery.Methods387 patients were randomised to receive either ondansetron 8 mg or placebo i.v. prior to anaesthesia induction. Anaesthesia was performed with a volatile anaesthetic, nitrous oxide and opioids. Established PONV was treated with ondansetron 4 mg i.v. Postoperative evaluation included time, duration and severeness of nausea and vomiting in the first 24 h after the operation.ResultsIn the study period the incidence of emesis was 35% after prophylactic ondansetron and 58% after placebo (p < 0.01). Nausea occurred in 49% and 64% respectively (p < 0.01). 28% after prophylactic ondansetron and 48% after placebo required ondansetron therapy (p < 0.01). The number of adverse events was small in total and comparable for both groups.ConclusionOur investigation proves the efficiency of ondansetron 8 mg prior to induction of anaesthesia in preventing PONV. Furthermore, our results demonstrate the safety of the drug for prophylaxis and therapy.

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