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

NCT ID: NCT01657786

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Nausea and Vomiting

Keywords

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ondanstron gene polymorphism postoperative nausea and vomiting laparoscopic surgery under general anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Ondansetron administration group

Group Type EXPERIMENTAL

administration of ondanstron and screening of genomic DNA

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Associate Professor Department of Anesthesiology and Pain Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2008-0075

Identifier Type: -

Identifier Source: org_study_id