BMC anesthesiology

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

PMID 25104916


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. 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 (4xa0mg; group A, n  =  55), ondansetron (8xa0mg; group B, n  =  54), or ramosetron (0.3xa0mg; 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 48xa0h postoperatively. 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 48xa0h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0-2xa0h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2-48xa0h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events. Intravenous administration of ramosetron at 0.3xa0mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3xa0mg was more effective than ondansetron at 4 or 8xa0mg for preventing PONV in adult craniotomy patients. CLINICAL RESEARCH INFORMATION SERVICE (CRIS) IDENTIFIER: KCT0000320. Registered 9 January 2012.