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

NCT ID: NCT01181492

Last Updated: 2013-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Pain Surgery

Keywords

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gene polymorphism CYP3A4 fentanyl HPLC Analgesics

Study Groups

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*1/*1

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

No interventions assigned to this group

*1/*1G

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

No interventions assigned to this group

*1G/*1G

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xianwei Zhang

Tongji Hospital, Tongji Medical College

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhang Xianwei, MD

Role: STUDY_DIRECTOR

Huazhong University of Science and Technology

Locations

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

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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HuazhongU

Identifier Type: -

Identifier Source: org_study_id