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

January 24, 2017 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
  • patient scheduled for elective gynecological laparoscopic surgery.

Exclusion Criteria:

  • hepatorenal disease
  • BMI > 35 kg/m2
  • allergy to ramosetron
  • gastrointestinal disease
  • vomiting within 24h
  • administration of antiemetics or opioids within 24h
  • QT prolongation (QTc > 440ms)
  • pregnant
  • problem with communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ramosetron 0.3
Drug: ramosetron 0.3
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
Active Comparator: ramosetron 0.45
Drug: ramosetron 0.45
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
Active Comparator: ramosetron 0.6
Drug: ramosetron 0.6
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative nausea and vomiting
Time Frame: within 48h after surgery
incidence of nausea and vomiting during the first 48 h after surgery
within 48h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

February 6, 2016

Study Completion (Actual)

February 6, 2016

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-1065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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