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

NCT02478645 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

ramosetron 0.3

The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.

DRUG

ramosetron 0.45

The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.

DRUG

ramosetron 0.6

The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478645 on ClinicalTrials.gov