title: Treatment of postoperative nausea and vomiting after outpatient surgery with the 5-HT3 antagonist ondansetron.
abstract: 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.
authors.affiliation: Department of Anesthesia, Bowman Gray School of Medicine, Wake Forest University Medical Center, Winston-Salem, North Carolina 27157-1009.
authors.forename: P
authors.initials: P
authors.lastname: Scuderi
authors.forename: B
authors.initials: B
authors.lastname: Wetchler
authors.forename: Y F
authors.initials: YF
authors.lastname: Sung
authors.forename: M
authors.initials: M
authors.lastname: Mingus
authors.forename: S
authors.initials: S
authors.lastname: DuPen
authors.forename: L
authors.initials: L
authors.lastname: Claybon
authors.forename: J
authors.initials: J
authors.lastname: Leslie
authors.forename: P
authors.initials: P
authors.lastname: Talke
authors.forename: J
authors.initials: J
authors.lastname: Apfelbaum
authors.forename: S
authors.initials: S
authors.lastname: Sharifi-Azad
mesh_terms: D000328:Adult; D000556:Ambulatory Surgical Procedures; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000517:prevention & control*; D017294:Ondansetron / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D014839:Vomiting / Q000517:prevention & control*
chemical_list: D017294:Ondansetron