Skip to main content
Current Therapeutic Research, Clinical and Experimental logoLink to Current Therapeutic Research, Clinical and Experimental
. 2004 Jul;65(4):321–329. doi: 10.1016/j.curtheres.2004.06.002

Treatment of postoperative emetic symptoms with granisetron in women undergoing abdominal hysterectomy: a randomized, double-blind, placebo-controlled, dose-ranging study

Yoshitaka Fujii 1,*, Hiroyoshi Tanaka 2, Yoshiaki Somekawa 3
PMCID: PMC3964540  PMID: 24672087

Abstract

Background

Postoperative emetic symptoms (nausea, retching, and vomiting) frequently occur in women undergoing general anesthesia for abdominal hysterectomy. In a previous report by us, granisetron, a selective serotonin receptor antagonist, was more effective than the traditional antiemetics, droperidol and metoclopramide, for the treatment of postoperative emetic symptoms in this population.

Objective

The aim of this study was to determine the optimal dose of granisetron for the treatment of emetic symptoms following abdominal hysterectomy.

Methods

This randomized, double-blind, placebo-controlled, dose-ranging study was conducted at Toride Kyodo General Hospital (Toride, Japan). Female patients aged 33 to 66 years experiencing postoperative emetic symptoms after abdominal hysterectomy were eligible for the study. Patients received IV granisetron at 1 of 4 doses (10, 20, 40, or 100 μg/kg) or placebo; they were then observed for 24 hours. Emetic symptoms and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

Results

A total of 100 patients (mean [SD] age, 45 [7] years [range, 33–66 years]) were enrolled (n = 20 in each group). No significant differences in patient demographic characteristics were observed between the groups. The number of patients in whom complete control of postoperative emetic symptoms, defined as being free of emetic symptoms and not needing rescue antiemetic medication for 24 hours after study drug administration, was established was significantly greater in 3 of the granisetron groups than in the placebo group (6 patients [30%]): granisetron 10 μg/kg, 7 patients (35%; P= NS); granisetron 20 μg/kg, 17 patients (85%; P = 0.001); granisetron 40 μg/kg, 17 patients (85%; P = 0.001); and granisetron 100 μg/kg, 16 patients (80%; P = 0.002). No clinically significant adverse events attributable to the study drug were observed in any group.

Conclusion

In this study of patients who experienced emetic symptoms after undergoing general anesthesia for abdominal hysterectomy, granisetron at doses ≥20 μg/kg was effective in the treatment of established postoperative emetic symptoms.

Keywords: nausea, retching, vomiting, antiemetics, selective serotonin receptor antagonist, granisetron, hysterectomy

References

  • 1.Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and preventionAnesthesiology. 1992;77:162–184. doi: 10.1097/00000542-199207000-00023. [DOI] [PubMed] [Google Scholar]
  • 2.Madej TH, Simpson KH. Comparison of the use of domperidone, droperidol, and metoclopramide in the prevention of nausea and vomiting following gynaecological surgery in day cases. Br J Anaesth. 1986;58:879–883. doi: 10.1093/bja/58.8.879. [DOI] [PubMed] [Google Scholar]
  • 3.Kenney GN, Oates JD, Leeser J. Efficacy of orally administered ondansetron in the prevention of postoperative nausea and vomiting: A dose ranging study. Br J Anaesth. 1992;68:466–470. doi: 10.1093/bja/68.5.466. [DOI] [PubMed] [Google Scholar]
  • 4.McKenzie R, Kovac A, O'Connor T. Comparison of ondansetron versus placebo to prevent postoperative nausea and vomiting in women undergoing ambulatory gynecologic surgery. Anesthesiology. 1993;78:21–28. doi: 10.1097/00000542-199301000-00005. [DOI] [PubMed] [Google Scholar]
  • 5.Diemunsh P, Conseiller C, Clyti N, Mamet JP, for the French Ondansetron Study Group Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting. Br J Anaesth. 1997;79:322–326. doi: 10.1093/bja/79.3.322. [DOI] [PubMed] [Google Scholar]
  • 6.Andrews PL, Bhandari P, Davey PT. Are all 5-HT3 receptor antagonists the same? Eur J Cancer. 1992;28A(Suppl 1):S2–S6. doi: 10.1016/0959-8049(92)90628-f. [DOI] [PubMed] [Google Scholar]
  • 7.Fujii Y, Tanaka H, Somekawa Y. Granisetron, droperidol, and metoclopramide for the treatment of established postoperative nausea and vomiting in women undergoing gynecologic surgery. Am J Obstet Gynecol. 2000;182:13–16. doi: 10.1016/s0002-9378(00)70484-4. [DOI] [PubMed] [Google Scholar]
  • 8.Beattie WS, Lindblad T, Buckley DN, Forrest JB. Menstruation increases the risk of nausea and vomiting after laparoscopy. A prospective randomized studyAnesthesiology. 1993;78:272–276. doi: 10.1097/00000542-199302000-00010. [DOI] [PubMed] [Google Scholar]
  • 9.Bermudez J, Boyle EA, Minter WD, Sanger GJ. The antiemetic potential of 5-hydroxytryptamine3 receptor antagonist BRL 43694. Br J Cancer. 1988;58:644–650. doi: 10.1038/bjc.1988.277. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 10.Carmichael J, Cantwell BMJ, Edwards CM. A pharmacokinetic study of granisetron (BRL 43694A), a selective 5-HT3 receptor antagonist: Correlation with antiemetic response. Cancer Chemother Pharmacol. 1989;24:45–49. doi: 10.1007/BF00254104. [DOI] [PubMed] [Google Scholar]
  • 11.Yarker YE, McTavish D. Granisetron. An update of its therapeutic use in nausea and vomiting induced by antineoplastic therapyDrugs. 1994;48:761–793. doi: 10.2165/00003495-199448050-00008. [DOI] [PubMed] [Google Scholar]
  • 12.Fujii Y, Tanaka H, Toyooka H. Optimal anti-emetic dose of granisetron for preventing postoperative nausea and vomiting. Can J Anaesth. 1994;41:794–797. doi: 10.1007/BF03011585. [DOI] [PubMed] [Google Scholar]
  • 13.McCormick CG. FDA alert: Current FDA report on droperidol status and basis for ‘Black Box’ warning. ASA Newsl. 2002;66:19. [Google Scholar]

Articles from Current Therapeutic Research, Clinical and Experimental are provided here courtesy of Elsevier

RESOURCES