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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01657786
• Collaborator: (none)
• Enrollment: 198
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Nausea and Vomiting	Dietary Supplement: administration of ondanstron and screening of genomic DNA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. 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) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associate Professor Department of Anesthesiology and Pain Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01657786
• Other Study ID Numbers: 4-2008-0075
• First Posted: Aug 6, 2012
• Last Update Posted: Aug 6, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Yonsei University: ondanstron; gene polymorphism; postoperative nausea and vomiting; laparoscopic surgery under general anesthesia
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Aug 6, 2012