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A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia

Taylor, Ann Margaret, Rosen, Michael, Diemunsch, Pierre A., Thorin, Dominique and Houweling, Peter L. 1997. A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia. Journal of Clinical Anesthesia 9 (8) , pp. 658-663. 10.1016/S0952-8180(97)00190-6

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Abstract

Study Objective: To compare the effectiveness of granisetron with placebo in the treatment of established postoperative nausea and vomiting (PONV). Design: Randomized, placebo-controlled study. Setting: 34 hospitals in Europe, Scandinavia, and South Africa. Patients: 519 ASA physical status I, II, and III patients who developed PONV within 4 hours of the end of surgery performed with general anesthesia. Interventions: Patients received a single intravenous dose of granisetron 0.1 mg, 1 mg, or 3 mg, or placebo when symptoms of nausea or vomiting were experienced. Additional rescue medication could be given at the investigator's discretion if nausea and vomiting were not controlled. Measurements and Main Results: At all doses investigated, granisetron was significantly more effective (p ≤ 0.001) than placebo in controlling vomiting: 38%, 46%, and 49% of patients receiving granisetron, 0.1 mg, 1.0 mg, and 3.0 mg, respectively, experienced no vomiting in the first 24 hours following drug administration, compared with 20% receiving placebo. There was a statistically significant linear relationship between vomiting control and granisetron dose (p < 0.001). Survival distributions of time to resolution of vomiting confirmed the statistically significant difference between patients receiving granisetron and those receiving placebo. Granisetron was well tolerated: the most common adverse experiences were pain, constipation, anemia, and headache, and the incidence of adverse experiences was not statistically significantly higher in any of the granisetron groups than in the placebo group. Conclusion: Granisetron was significantly more effective than placebo in all groups. Further studies in specific subgroups may be warranted.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > RD Surgery
R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords: Granisetron; postoperative nausea and vomiting; 5-HT3 receptors
Publisher: Elsevier
ISSN: 0952-8180
Last Modified: 04 Jun 2017 04:29
URI: http://orca-mwe.cf.ac.uk/id/eprint/39829

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