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Clinical therapeutics · Feb 2003
Randomized Controlled Trial Comparative Study Clinical TrialGranisetron versus granisetron/dexamethasone combination for the treatment of nausea, retching, and vomiting after major gynecologic surgery: a randomized, double-blind study.
- Yoshitaka Fujii and Hiroyoshi Tanaka.
- Department of Anesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@igaku.md.tsukuba.ac.jp
- Clin Ther. 2003 Feb 1;25(2):507-14.
BackgroundGranisetron, a selective 5-hydroxytryptamine3 antagonist, is effective for the treatment of patients with postoperative nausea and vomiting. Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen.ObjectiveThis study compared the efficacy of granisetron alone with granisetron/dexamethasone combination for the treatment of nausea and vomiting after major gynecologic surgery.MethodsIn this randomized, double-blind study, patients who were experiencing emetic symptoms during 0 to 3 hours after the end of anesthesia administration received granisetron 40 microg/kg i.v. either alone or in combination with dexamethasone 8 mg. Patients then were observed for 24 hours after study drug administration, with emetic episodes recorded and tolerability assessments performed by nursing staff blinded to treatment.ResultsA total of 120 women were enrolled (n = 60 in each treatment group; mean [SD] age in the granisetron group, 44 [9] years [range, 23-63 years]; combination group, 45 [8] years [range, 21-65 years]). No significant differences in patient demographic characteristics were found between the 2 treatment groups. However, the percentage of patients free of emetic symptoms (nausea, retching, vomiting) was higher in the granisetron/dexamethasone combination group than in the granisetron group (95.0% and 80.0%, respectively; P = 0.012). No clinically serious adverse events attributed to the study drugs were observed in either group.ConclusionIn this study, the granisetron/dexamethasone combination was more effective than was granisetron alone for the management of nausea and vomiting during 0 to 3 hours after anesthesia in women undergoing major gynecologic surgery.
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