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

Post Operative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657786
• Other study ID #: 4-2008-0075
• Status: Completed
• Phase: N/A
• First received: July 28, 2012
• Last updated: August 3, 2012
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nausea
• Post Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Associate Professor Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	No