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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Surgery

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan,, Hubei, China, 430030
      • 1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

176 Chinese patients receiving elective lower abdominal surgery under general anesthesia

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
*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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual Analog Scale 24 Hours Postoperative	The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation	24 hours after operation
PCA Fentanyl Consumption	PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.	24 h after surgery

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Zhang Xianwei, MD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: fentanyl; CYP3A4; gene polymorphism; Analgesics; HPLC
• Other Study ID Numbers: HuazhongU