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

Abstract

This 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.

Methods: 387 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.

Results: In 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.

Conclusion: Our 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.