drugset / Trial / NCT03017222

Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery

NCT03017222

Completed 80 enrolled Yonsei University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.

Timeline

Start
2015-09-07
Primary completion
2016-04-02
Completion
2016-04-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 4 mg Intravenous
Subject Ramosetron Small molecule 0.3 mg Intravenous

Indications

No indication recorded.