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

Abstract

BackgroundPostoperative 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.MethodsPatients 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.ResultsAmong 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.ConclusionWe 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.

Prevention and Treatment of Postoperative Nausea and Vomiting (PONV): A Review of Current Recommendations and Emerging Therapies

“…In patients with established PONV (with or without prior PONV prophylaxis), common rescue treatment includes ondansetron, promethazine, and droperidol. [89][90][91] Several additional rescue treatments have been proposed, as summarized below.…”

Comparison of ramosetron and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery: a meta-analysis of randomized controlled trials

“…Of the 17 remaining studies considered eligible for the detailed evaluation, 11 articles were excluded as irrelevant after reviewing the full manuscript. Finally, the data from six studies [19][20][21][23][24][25] involving 361 patients in the ondansetron group and 326 patients in the ramosetron group were included in the meta-analysis. A detailed flow diagram of the study selection process is presented in Figure 1.…”

“…As shown in Figure 3, five studies 19,20,[23][24][25] in 614 patients examined the incidence of POV (ondansetron, n ¼ 326; ramosetron, n ¼ 288). A meta-analysis of the results of these studies showed that there was no statistically significant difference in the incidence of POV between the two treatment groups at different time intervals within the 24-hour period after laparoscopic surgery.…”

“…Four of the included studies 20,21,23,25 reported the side effects (headache, dizziness, drowsiness) experienced by patients treated with ramosetron or ondansetron during the 48-hour period after laparoscopic surgery. A pooled analysis based on a fixed-effects model did not reveal significant differences between the ondansetron and ramosetron groups for incidence of headache (RR, 0.57; 95% CI, 0.28-1.17), dizziness (RR, 0.98; 95% CI, 0.55-1.74), or drowsiness (RR, 0.98; 95% CI, 0.55-1.75) (Figure 4).…”

“…17,18 The first report describing 5HT3R antagonist therapy for the prevention of PONV in patients undergoing laparoscopic surgery was published in 2010. 19 Although several randomized controlled trials (RCTs) have since been conducted to compare the efficacy and safety of ondansetron and ramosetron for the prevention of PONV after laparoscopic surgery, [19][20][21] the conclusions have been somewhat inconsistent. Accordingly, it remains unclear whether ramosetron is more effective than ondansetron for the prevention of PONV in patients after laparoscopic surgery.…”