Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

March 19, 2016 updated by: Kidong Kim, Seoul National University Hospital
We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

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
    • Gyeonggi Do
      • Seongnam Si, Gyeonggi Do, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Laparoscopy for benign gynecologic disease

Exclusion Criteria:

  • Vomiting within 24 hours before surgery
  • Not using patient controlled analgesics postoperatively

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.
Drug: Ramosetron
Experimental: Experimental
Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.
Drug: Ramosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: Postoperative 24 hours
The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery
Postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_GO_017

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.

Clinical Trials on Postoperative Nausea and Vomiting

Clinical Trials on Ramosetron

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe