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Comparison of ramosetron and ondansetron for the treatment of established postoperative nausea and vomiting after laparoscopic surgery: a prospective, randomized, double-blinded multicenter trial

Authors
 Yong Seon Choi  ;  Hye-Min Sohn  ;  Sang-Hwan Do  ;  Kyeong Tae Min  ;  Jae Hee Woo  ;  Hee Jung Baik 
Citation
 THERAPEUTICS AND CLINICAL RISK MANAGEMENT, Vol.14 : 601-606, 2018 
Journal Title
 THERAPEUTICS AND CLINICAL RISK MANAGEMENT 
ISSN
 1176-6336 
Issue Date
2018
Keywords
antiemetic ; laparoscopic surgery ; non-inferiority ; ondansetron ; postoperative nausea and vomiting ; ramosetron
Abstract
Background: Postoperative nausea and vomiting (PONV) is a common complication after surgery, which increases physical and psychological discomfort and delays recovery. The aim of this study was to test the hypothesis that ramosetron is comparable to ondansetron for the treatment of established PONV after laparoscopic surgery using a prospective, randomized, double-blinded, noninferiority study. Methods: Patients who had at least two risk factors of PONV and underwent laparoscopic surgery under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 h after anesthesia received ondansetron (4 mg) or ramosetron (0.3 mg) intravenously in a randomized double-blind manner. Patients were then observed for 24 h after drug administration. The incidence of nausea and vomiting, severity of nausea, rescue antiemetic necessity, and adverse effects at 0-2 or 2-24 h after drug administration was evaluated. The primary endpoint was the rate of patients exhibiting a complete response, defined as no emesis and no further rescue antiemetic medication for 24 h after drug administration. Results: Among the 583 patients, 210 (36.0%) developed PONV and were randomized to either the ondansetron (n=105) or ramosetron (n=105) group. Patient's characteristics were similar between the groups. The complete response rate was 44.1% in the ondansetron group and 52.9% in the ramosetron group after 24 h of initial antiemetic administration. The incidence of adverse events was not different between the groups. Conclusion: We found evidence to support the noninferiority of ramosetron (0.3 mg) compared to ondansetron (4 mg) for the treatment of established PONV in moderate to high-risk patients undergoing laparoscopic surgery.
Files in This Item:
T201801724.pdf Download
DOI
10.2147/tcrm.s159211
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Anesthesiology and Pain Medicine (마취통증의학교실) > 1. Journal Papers
Yonsei Authors
Min, Kyeong Tae(민경태) ORCID logo https://orcid.org/0000-0002-3299-4500
Choi, Yong Seon(최용선) ORCID logo https://orcid.org/0000-0002-5348-864X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/162485
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