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

BMC Anesthesiology

Research Article

Jong-In Han¹  Hee-Jung Baik¹  Jung-Hee Ryu²  Sang-Hwan Do²  Ji-Eun Lee³  Young-Jin Lim⁴  Deok-Man Hong⁴  Hee-Pyoung Park⁴  Hyun-Zu Kim⁵  Kyeong-Tae Min⁵ 

[1] Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Seoul, South Korea;Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, 463-707, Seongnam-si, Gyeonggi-do, South Korea;Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea;Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea;Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea;Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea;Department of Anesthesiology and Pain Medicine, Severance Hospital, Seoul, South Korea;

关键词: Craniotomy;    Ondansetron;    Postoperative nausea and vomiting;    Ramosetron;   

DOI  :  10.1186/1471-2253-14-63

 received in 2014-03-21, accepted in 2014-07-28,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundCraniotomy 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.MethodsA 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.ResultsAmong 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.ConclusionIntravenous 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 registrationClinical Research Information Service (CRiS) Identifier: KCT0000320. Registered 9 January 2012.

【 授权许可】

Unknown   
© Ryu et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.