TY - JOUR
T1 - Treatment of postoperative nausea and vomiting after outpatient surgery with the 5-HT3 antagonist ondansetron
AU - Scuderi, P.
AU - Wetchler, B.
AU - Sung, Y. F.
AU - Mingus, M.
AU - DuPen, S.
AU - Claybon, L.
AU - Leslie, J.
AU - Talke, P.
AU - Apfelbaum, J.
AU - Sharifi-Azad, S.
AU - Williams, M. F.
PY - 1993
Y1 - 1993
N2 - 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.
AB - 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.
KW - Antagonists, serotonin: ondansetron
KW - Complications, postoperative: nausea; vomiting
KW - Receptors, 5-HT: serotonin
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U2 - 10.1097/00000542-199301000-00004
DO - 10.1097/00000542-199301000-00004
M3 - Article
C2 - 8424548
AN - SCOPUS:0027446215
SN - 0003-3022
VL - 78
SP - 15
EP - 20
JO - Anesthesiology
JF - Anesthesiology
IS - 1
ER -