Treatment of postoperative nausea and vomiting after outpatient surgery with the 5-HT3 antagonist ondansetron

Anesthesiology. 1993 Jan;78(1):15-20. doi: 10.1097/00000542-199301000-00004.


Background: Postoperative nausea and vomiting following outpatient surgery can significantly delay discharge. This study evaluates the safety and efficacy of ondansetron (a new 5-HT3 antagonist) in the treatment of postoperative nausea and vomiting in patients following outpatient surgery.

Methods: Five hundred outpatient surgical patients (53 male and 447 female), receiving general endotracheal anesthesia, were studied at ten centers. Patients were stratified by gender and received, in a randomized, double-blind manner, 1, 4, or 8 mg ondansetron or placebo in response to nausea and/or vomiting postoperatively. Episodes of vomiting, nausea scores, adverse events, vital signs, and laboratory values were evaluated before and during the 24 h after study drug administration.

Results: Complete response to study medication (no vomiting and/or retching, and no rescue antiemetic over the initial 0-2-h period) was more frequent in the ondansetron groups (1 mg 57%, 4 mg 61%, and 8 mg 57%) than in the placebo group (30%, P < .001). For the 0-24-h study a complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% of the 1-, 4-, and 8-mg ondansetron groups, respectively (P < .001 for all comparisons with placebo). Median nausea scores (range 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron (1.3, 0.8, 1.8 for 1, 4, and 8 mg, respectively) as compared with placebo (2.3). No significant differences occurred in hemodynamic stability, incidence of adverse events, or changes in laboratory values in the ondansetron groups compared to the placebo group.

Conclusions: Ondansetron, in doses less than 8 mg, is a safe, effective antiemetic for treating postoperative nausea and vomiting.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Ambulatory Surgical Procedures*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Nausea / prevention & control*
  • Ondansetron / therapeutic use*
  • Postoperative Complications / prevention & control*
  • Vomiting / prevention & control*


  • Ondansetron