ONDANSETRON PREVENTS POSTOPERATIVE EMESIS IN MALE OUTPATIENTS

Study Objectives: To determine (1) the efficacy and safety of ondanset ron in the prevention of postoperative nausea and vomiting (PONV) in m ale outpatients; (2) prognostic factors for PONV in male outpatients; and (3) patients' perceptions of the debilitating effects of PONV in t he ambulatory surgery setting. Design: Prospective, randomized, strati fied, double-blind study. Setting: Multicemter-24 medical centers. Pat ients: 468 ASA physical status I and II males at least 12 years of age scheduled for general anesthesia. Interventions: Abl patients receive d intravenous ondansetron 4 rng or placebo prior to undergoing general balanced (opioid) anesthesia. Measurements and Main Results: In the p ostanesthesia care unit (PACU), the number of emetic episodes, vital s igns, adverse events, and nausea assessments were recorded tf a blinde d observer. After discharge and until the end of the 24-hour study per iod, patients completed a diary that collected emetic episodes, advers e events, nausea, and pharmacoecono mtc data. There were no difference s in patient demographics or safety profiles between groups. The numbe r of patients with no emesis and no nausea during the 24-hour study pe riod was significantly greater (p < 0.05) with ondansetron 4 mg compar ed with placebo. Prognostic factors for an increased likelihood of dev eloping PONV in males included a history of motion sickness or previou s PONV patients undergoing nonorthopenic procedures, and surgeries las ting longer than one hour. Finally 38% of patients experiencing PONV p erceived PONV to be as, or more debilitating than, the aftereffects of surgery itself. Conclusions: Ondansetron 4 mg was more effective than Placebo in preventing PONV in male outpatients. Males at potential ri sk for developing PONV include: (1) those with a history of motion sic kness and/or PONV; (2) patients undergoing nonorthopedioc procedures; and (3) procedures lasting longer than one hour. Such patients may ben efit from receipt of a prophylactic antiemetic. Postoperative nausea a nd vomiting has a debilitating effect that can be differentiated by pa tients from the effects of surgery itself. (C) 1996 by Elsevier Scienc e Inc.