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NCT02478645

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

Completed Phase 4 Last updated 25 January 2017
What this trial tests

Phase 4 trial testing ramosetron 0.3 in Postoperative Nausea and Vomiting in 177 participants. Completed in 6 February 2016.

Timeline
19 June 2015
Primary endpoint
6 February 2016
6 February 2016

Quick facts

Lead sponsorYonsei University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment177
Start date19 June 2015
Primary completion6 February 2016
Estimated completion6 February 2016
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

Adults 20 to 70, any sex, with Postoperative Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Dose-Ranging Study of Ramosetron for the Prevention of Nausea and Vomiting after Laparoscopic Gynecological Surgery: A Prospective Randomized Study.
    Cho JS, Kim SW, Lee S, Yoo YC. · · 2019 · cited 5× · PMID 31835896 · DOI 10.3390/jcm8122188

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Other recruiting trials for Postoperative Nausea and Vomiting

Currently open trials in the same condition.

Other Yonsei University trials

Trials by the same sponsor.

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Data sources for this page

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