Association of 5-HT3 Receptor Gene Polymorphism With the Efficiency of Ondansetron for Postoperative Nausea and Vomiting

August 3, 2012 updated by: Yonsei University
Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have significantly reduced PONV, it is reported that over 35% of patients treated with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would contribute to such inter-individual variation. In this study, the investigators examine whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

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
      • Seoul, Korea, Republic of, 120-752
        • Associate Professor Department of Anesthesiology and Pain Medicine

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (20-90 years of age) scheduled for undergoing laparoscopic surgery undergoing general anesthesia

Exclusion Criteria:

  • Patients with previous history of drug allergy,
  • administration of antiemetic drugs within 24 hours,
  • nausea/vomiting within 24 hours and liver or kidney disease

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ondansetron administration group
Dietary supplement: administration of ondanstron and screening of genomic DNA
Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg is administered intravenously. We assess an episode of PONV at first 2 h and 2-24 h after surgery. Genomic DNA was prepared and screened. The incidence of PONV is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between the incidence of PONV after ondansetron administration and genotypes in 5-HT3 receptor gene polymorphisms ((5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG)
Time Frame: at first 2 h and 2-24 h after surgery.
The incidence of PONV after ondansetron administration is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG).
at first 2 h and 2-24 h 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

May 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 28, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2008-0075

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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