ONDANSETRON FOR PONV PROPHYLAXIS AND THERAPY IN MAJOR GYNECOLOGICAL SURGERY - RESULTS OF A NATIONAL MULTICENTER STUDY

This investigation was conducted as a national multicenter study to ev aluate effectiveness and safety of prophylactic and therapeutic ondans etron for postoperative nausea and vomiting (PONV) in major gynaecolog ical surgery. Methods: 387 patients were randomised to receive either ondansetron 8 mg or placebo i.v. prior to anaesthesia induction. Anaes thesia was performed with a volatile anaesthetic, nitrous oxide and op ioids. Established PONV was treated with ondansetron 4 mg i.v.. Postop erative evaluation included time, duration and severeness of nausea an d vomiting in the first 24 h after the operation. Results: in the stud y period the incidence of emesis was 35% after prophylactic ondansetro n and 58% after placebo (p<0.01). Nausea occurred in 49% and 64% respe ctively (p<0.01)28% after prophylactic ondansetron and 48% after place bo required ondansetron therapy (p<0.01). The number of adverse events was small in total and comparable for both groups. Conclusion: Our in vestigation proves the efficiency of ondansetron 8 mg prior to inducti on of anaesthesia in preventing PONV. Furthermore, our results demonst rate the safety of the drug for prophylaxis and therapy.