The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

December 30, 2009 updated by: Seoul National University Bundang Hospital
Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

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, 463-707
        • Recruiting
        • Jung-Hee Ryu
        • Contact:

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I
0.3 mg IV ramosetron
Drug: intravenous ramosetron
0.3 mg IV ramosetron (group I)
Active Comparator: group II
0.1 mg oral ramosetron
Drug: oral ramosetron
0.1 mg oral ramosetron (group II)
Active Comparator: group III
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron
Drug: oral and IV ramosetron
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PONV
Time Frame: postoperative 0-48 h
postoperative 0-48 h

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2009

Last Update Submitted That Met QC Criteria

December 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nasea-LC

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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