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Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults.
J Anesth. 2004; 18(3):158-65.JA

Abstract

PURPOSE

This randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, and optimal dose of granisetron in the prophylactic control of postoperative nausea and vomiting in patients undergoing gynecologic surgery or cholecystectomy.

METHODS

Three-hundred and fifteen patients (age, 20-65 years) received intravenous granisetron (1 mg or 3 mg) or placebo immediately before the end of anesthesia. After treatment, patients were observed for 24 h, and the occurrence of nausea and vomiting was recorded and safety was assessed. The no-vomiting rate, time-to-first vomiting episode, and severity of nausea were recorded.

RESULTS

The no-vomiting rates in patients receiving granisetron 1 mg and 3 mg were significantly higher than that in the placebo group (83.7%, 78.8%, and 57.9%, respectively; P = 0.0004 for 1 mg vs placebo, P = 0.001 for 3 mg). Time-to-first vomiting episode was longer in the granisetron 1-mg and 3-mg groups than in the placebo group (time-to-event analysis, Kaplan-Meier, log-rank test; 83.2%, 80.1%, and 59.1%, respectively; P = 0.0002 and P = 0.0010). The severity of nausea was also less in granisetron-treated patients (25.2%, 11.5%, and 15.4% severe nausea incidence for placebo, granisetron 1 mg, and granisetron 3 mg, respectively; P = 0.00003 and P = 0.002). Fewer rescue medications were required in the two granisetron-treated groups compared with those receiving placebo. Adverse events were similar in all groups. No differences in efficacy or safety were observed between granisetron doses.

CONCLUSION

Granisetron is well-tolerated and more effective than placebo in the prophylactic control of nausea and vomiting after surgery. This study suggests that the optimum dose of granisetron is 1 mg.

Authors+Show Affiliations

Department of Anesthesiology, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, 113-8655 Tokyo, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15290412

Citation

Hanaoka, Kazuo, et al. "Efficacy of Prophylactic Intravenous Granisetron in Postoperative Emesis in Adults." Journal of Anesthesia, vol. 18, no. 3, 2004, pp. 158-65.
Hanaoka K, Toyooka H, Kugimiya T, et al. Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults. J Anesth. 2004;18(3):158-65.
Hanaoka, K., Toyooka, H., Kugimiya, T., & Ohashi, Y. (2004). Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults. Journal of Anesthesia, 18(3), 158-65.
Hanaoka K, et al. Efficacy of Prophylactic Intravenous Granisetron in Postoperative Emesis in Adults. J Anesth. 2004;18(3):158-65. PubMed PMID: 15290412.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults. AU - Hanaoka,Kazuo, AU - Toyooka,Hidenori, AU - Kugimiya,Toyoki, AU - Ohashi,Yasuo, AU - ,, PY - 2003/11/11/received PY - 2004/02/12/accepted PY - 2004/8/4/pubmed PY - 2004/11/4/medline PY - 2004/8/4/entrez SP - 158 EP - 65 JF - Journal of anesthesia JO - J Anesth VL - 18 IS - 3 N2 - PURPOSE: This randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, and optimal dose of granisetron in the prophylactic control of postoperative nausea and vomiting in patients undergoing gynecologic surgery or cholecystectomy. METHODS: Three-hundred and fifteen patients (age, 20-65 years) received intravenous granisetron (1 mg or 3 mg) or placebo immediately before the end of anesthesia. After treatment, patients were observed for 24 h, and the occurrence of nausea and vomiting was recorded and safety was assessed. The no-vomiting rate, time-to-first vomiting episode, and severity of nausea were recorded. RESULTS: The no-vomiting rates in patients receiving granisetron 1 mg and 3 mg were significantly higher than that in the placebo group (83.7%, 78.8%, and 57.9%, respectively; P = 0.0004 for 1 mg vs placebo, P = 0.001 for 3 mg). Time-to-first vomiting episode was longer in the granisetron 1-mg and 3-mg groups than in the placebo group (time-to-event analysis, Kaplan-Meier, log-rank test; 83.2%, 80.1%, and 59.1%, respectively; P = 0.0002 and P = 0.0010). The severity of nausea was also less in granisetron-treated patients (25.2%, 11.5%, and 15.4% severe nausea incidence for placebo, granisetron 1 mg, and granisetron 3 mg, respectively; P = 0.00003 and P = 0.002). Fewer rescue medications were required in the two granisetron-treated groups compared with those receiving placebo. Adverse events were similar in all groups. No differences in efficacy or safety were observed between granisetron doses. CONCLUSION: Granisetron is well-tolerated and more effective than placebo in the prophylactic control of nausea and vomiting after surgery. This study suggests that the optimum dose of granisetron is 1 mg. SN - 0913-8668 UR - https://www.unboundmedicine.com/medline/citation/15290412/Efficacy_of_prophylactic_intravenous_granisetron_in_postoperative_emesis_in_adults_ L2 - https://dx.doi.org/10.1007/s00540-004-0236-6 DB - PRIME DP - Unbound Medicine ER -