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

NCT01657786 | Completed DMC

• 1 other identifier: 4-2008-0075
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Nausea and Vomiting

Keywords

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

Outcome Measures

Primary Outcomes (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)

  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.

Study Arms (1)

Ondansetron administration group

EXPERIMENTAL

Dietary Supplement: administration of ondanstron and screening of genomic DNA

Interventions

administration of ondanstron and screening of genomic DNA 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).

Ondansetron administration group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Associate Professor Department of Anesthesiology and Pain Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

KR (1)