Open Access Research article

A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetron on postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron

Jung-Hee Ryu13, Ji-Eun Lee2, Young-Jin Lim23, Deok-Man Hong23, Hee-Pyoung Park23, Jong-In Han4, Hee-Jung Baik4, Hyun-Zu Kim5, Kyeong-Tae Min5 and Sang-Hwan Do13*

Author Affiliations

1 Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, South Korea

2 Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea

3 Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea

4 Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Seoul, Korea

5 Department of Anesthesiology and Pain Medicine, Severance Hospital, Seoul, South Korea

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BMC Anesthesiology 2014, 14:63  doi:10.1186/1471-2253-14-63

Published: 4 August 2014

Abstract

Background

Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients.

Methods

A total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n  =  55), ondansetron (8 mg; group B, n  =  54), or ramosetron (0.3 mg; group C, n  =  51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively.

Results

Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P  <  0.001; vomiting, P  =  0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P  <  0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events.

Conclusion

Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8 mg for preventing PONV in adult craniotomy patients.

Trial registration

Clinical Research Information Service (CRiS) Identifier: KCT0000320. Registered 9 January 2012.

Keywords:
Craniotomy; Ondansetron; Postoperative nausea and vomiting; Ramosetron