drugset / Trial / NCT02478645

Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery

NCT02478645

Phase 4 Completed 177 enrolled Yonsei University
RandomizedParallel-groupTriple-blindOther

Summary

Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.

Timeline

Start
2015-06-19
Primary completion
2016-02-06
Completion
2016-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramosetron Small molecule 0.3 mg
Subject Ramosetron Small molecule 0.45 mg
Subject Ramosetron Small molecule 0.6 mg

Indications

No indication recorded.