Comparison of Ondansetron and Placebo for Preventing Postoperative Nausea and Emesis in Gastrointestinal Tract Surgery : A Multicenter Randomized Controlled Trial
ORANUCH KYOKONG, M.D.*, SHUSEE VISALYAPUTRA, M.D.**, PRAMOTE SARA TAN, M.D.****, WANNA SOMBOONVIBOON, M.D.*, SOMSRI PAUSAWADI,M.D.***, PRAMOTE VONGVISES, M.D.*****
Affiliation : * Department of Anesthesiology, Faculty of Medicine, Chulalongkom University, Bangkok 10330, ** Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, *** Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, **** Department of Anesthesia, Rajvithi Hospital, Bangkok 10400, ***** Division of Anesthesiology, Phramongkutklao Hospital, Bangkok 10400, Thailand. t This work was carried out at Chulalongkom Hospital, Siriraj Hospital, Ramathibodi Hospital, Rajvithi Hospital and Phramongkutklao Hospital, Bangkok, Thailand. Supported by Glaxo Wellcome (Thailand) Ltd. Presented in part at the 9th Asian & Australasian Congress of Anesthesiologists, Bangkok, Thailand, November 6-11, 1994.
Background : Nausea and emesis are undesirable events that may cause discomfort and
suffering in the postoperative period. This study was carried out to evaluate the efficacy and safety of
ondansetron for preventing postoperative nausea and vomiting in patients undergoing gastrointes-
tinal tract surgery.
Method : Using a randomized double-blind study design, 408 surgical patients (163 male
and 245 female) receiving general endotracheal anesthesia were studied at five medical centers
in Bangkok. Ondansetron (4 mg) or placebo was administered prior to induction of anesthesia.
Episodes of nausea and vomiting, adverse events and laboratory tests (complete blood count and
liver function test) were evaluated during 24 hours after study drug administration.
Results : The incidence of postoperative nausea and vomiting in the placebo group (42.7
and 35.2%) were significantly higher than the ondansetron group (23.9 and 15.4%). However, no
significant differences occurred in the incidence of adverse events or changes in laboratory tests
in the ondansetron group compared to the placebo group.
Conclusions : Ondansetron 4 mg given intravenously before surgery is safe and effective
for preventing postoperative nausea and emesis following gastrointestinal tract surgery.
Keywords : Nausea and Emesis, Gastrointestinal Tract Surgery, Ondansetron, Placebo, Com- parison, Multicenter Trial
