Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery

NCT01181492 | Completed Results DMC

• 1 other identifier: HuazhongU
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4\*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.

Conditions

Pain; Surgery

Keywords

gene polymorphism; CYP3A4; fentanyl; HPLC; Analgesics

Outcome Measures

Primary Outcomes (1)

• CYP3A4*1G Polymorphism

  According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G

  48 hours after operation

Secondary Outcomes (2)

• The Visual Analog Scale 24 Hours Postoperative

  24 hours after operation

• PCA Fentanyl Consumption

  24 h after surgery

Study Arms (3)

*1/*1

Grouped by CYP3A4\*1G polymorphism, wild-type homozygote

*1/*1G

Grouped by CYP3A4\*1G polymorphism,\*1/\*1G: mutant heterozygote

*1G/*1G

Grouped by CYP3A4\*1G polymorphism,\*1G/\*1G: mutant homozygote

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

176 Chinese patients receiving elective lower abdominal surgery under general anesthesia

You may qualify if:

• Aged 20-65 years
• Anesthesiologists (ASA) physical status I or II;
• With ±20% of ideal body weight;
• Received PCA administration;
• Agreed to participate the research

You may not qualify if:

• History of chronic pain;
• Psychiatric diseases;
• Diabetes mellitus;
• Severe cardiovascular diseases;
• Kidney or liver diseases;
• Alcohol or drug abuse (according to the criteria of DSM-IV);
• Pregnancy or at lactation period;
• Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;
• Refused PCA administration;
• Disagree to participate to the research

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

176 blood samples were extracted

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The preoperative and postoperative data were not all integrallty recorded in a relative short period and entered into Excel.

Results Point of Contact

• Title: Zhang Xianwei
• Organization: Huazhong University of Science&Technology

ourpain@163.com

027 83662853

Study Officials

• Zhang Xianwei, MD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tongji Hospital, Tongji Medical College

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: November 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 1, 2013
• Results First Posted: November 1, 2013

Record last verified: 2013-08

Locations

CN (1)