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

Completed

• Conditions: Pain; Surgery

• Registration Number: NCT01181492
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Results First Submitted: 2012-12-04
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-28
• Last Update Submitted: 2013-08-28
• Results First Posted: 2013-11-01
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CYP3A4*1G Polymorphism	48 hours after operation	According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G

Secondary Outcome Measures

Name	Time	Method
The Visual Analog Scale 24 Hours Postoperative	24 hours after operation	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
PCA Fentanyl Consumption	24 h after surgery	PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.

Trial Locations

Locations (1)

1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan,, Hubei, China