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Dolasetron for the prevention of postoperative nausea and vomiting following outpatient surgery with general anaesthesia: a randomized, placebo-controlled study

Published online by Cambridge University Press:  16 August 2006

B. K. Philip
Affiliation:
Brigham and Women's Hospital, Boston, MA, USA
M. H. Pearman
Affiliation:
Baptist Medical Center, Columbia, SC, USA
A. L. Kovac
Affiliation:
University of Kansas Medical Center, Kansas City, KS, USA
J. E. Chelly
Affiliation:
University of Texas, Houston, TX, USA
B. V. Wetchler
Affiliation:
Methodist Medical Center of Illinois, Peoria IL, USA
R. McKenzie
Affiliation:
Magee-Woman's Hospital, Pittsburgh, PA, USA
T. G. Monk
Affiliation:
Washington University Hospital, St. Louis, MO, USA
M. Dershwitz
Affiliation:
Massachusetts General Hospital, Boston MA, USA
M. Mingus
Affiliation:
Mount Sinai Center, New York, NY, USA
Y. F. Sung
Affiliation:
ASC/The Emory Clinic, Atlanta, GA, USA
W. F. Hahne
Affiliation:
Hoechst Marion Roussel, Kansas City, MO, USA
R. A. Brown
Affiliation:
Hoechst Marion Roussel, Kansas City, MO, USA
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Abstract

In a multicentre, randomized, double-blind, placebo-controlled dose-ranging study, 1030 patients undergoing outpatient surgery with general anaesthesia received i.v. dolasetron mesylate (12.5, 25, 50, or 100 mg) or placebo. The principal outcome measure was the proportion of patients who were free of emesis or rescue medication for the 24-h period after the study drug was given; the subsidiary outcome measure was survival time without rescue medication. Effects on nausea were quantified using a visual analogue scale. Compared with placebo, a complete response was significantly higher when all four dolasetron doses were combined (49% vs. 58%, P = 0.025). In females, dolasetron, 12.5-mg, dolasetron provided maximum clinical benefit (effectiveness compared with adverse events), with no additional benefit in complete response rates or nausea visual analogue scale scores at higher doses. No significant differences were observed in complete response for any dolasetron dose in males compared with placebo. The majority of adverse events reported were mild or moderate. Dolasetron provided well-tolerated, safe, and effective prophylaxis for post-operative nausea and vomiting with maximum effectiveness observed at a dose of 12.5 mg.

Type
Original Article
Copyright
2000 European Society of Anaesthesiology

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