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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.

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.

SUBMITTER: Choi YS

PROVIDER: S-EPMC5875401 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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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.

Choi Yong Seon YS Sohn Hye-Min HM Do Sang-Hwan SH Min Kyeong Tae KT Woo Jae Hee JH Baik Hee Jung HJ

Therapeutics and clinical risk management 20180326

<h4>Background</h4>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.<h4>Methods</h4>Patients who had at least two risk factors of PONV and underwent laparoscopic su ...[more]

PMID: 29618928

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Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

Project description:This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis.This was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron.Of 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p?=?0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p?=?0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p?=?0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.ClinicalTrials.gov, NCT00967499 (Registered August 27, 2009).

Project description:BackgroundPostoperative nausea and vomiting is a distressing complication of surgery, and 5-HT3 receptor antagonists are often prescribed to prevent it. Ondansetron is the agent typically administered to prevent postoperative nausea and vomiting. Although ramosetron has a longer duration of action than ondansetron, it remains unclear whether ramosetron is the more effective medication. We performed an updated meta-analysis on the comparative efficacy of ramosetron and ondansetron in preventing postoperative nausea and vomiting.MethodsWe searched six databases for all trials that randomly assigned patients to ramosetron or ondansetron groups. The primary outcome was postoperative nausea or vomiting in the early, late, and next-day periods. The secondary outcomes were side effects of the medications. We used the random-effects model to combine the results. Trial sequential analyses were performed to correct for repetitive testing in the updated meta-analysis.ResultsTwenty-seven randomized controlled trials with 3,811 patients were included in the meta-analysis. The combined results of ramosetron vs. ondansetron efficacy in preventing postoperative nausea and vomiting were as follows: Risk ratio [95% confidence interval] = 0.82 [0.69-0.98] for early postoperative nausea, 0.76 [0.65-0.89] for late postoperative nausea, 0.69 [0.57-0.84] for next-day postoperative nausea, 0.78 [0.63-0.98] for early postoperative vomiting, 0.57 [0.45-0.72] for late postoperative vomiting, and 0.61 [0.43-0.86] for next-day postoperative vomiting. Dizziness was significantly lower in ramosetron groups than in ondansetron groups (risk ratio [95% confidence interval] = 0.81 [0.66-0.98]). Trial sequential analysis revealed that the results for late postoperative nausea, late postoperative vomiting, and next-day postoperative nausea were conclusive.ConclusionsRamosetron is more effective in preventing late postoperative nausea, late postoperative vomiting, and next-day postoperative nausea than ondansetron. The incidence of dizziness may be lower in patients receiving ramosetron than in patients receiving ondansetron.Trial registrationUniversity hospital Medical Information Network Clinical Trials Registry: UMIN000022980.

Dataset Information

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

Publications

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

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