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

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ClinicalTrials.gov Identifier: NCT01181492
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology

Study Description
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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.

Condition or disease
Pain Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 176 participants
Official Title: Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. CYP3A4*1G Polymorphism [ Time Frame: 48 hours after operation ]
    According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G


Secondary Outcome Measures :
  1. The Visual Analog Scale 24 Hours Postoperative [ Time Frame: 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

  2. PCA Fentanyl Consumption [ Time Frame: 24 h after surgery ]
    PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.


Biospecimen Retention:   Samples With DNA
176 blood samples were extracted

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
176 Chinese patients receiving elective lower abdominal surgery under general anesthesia
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181492


Locations
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China, Hubei
1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan,, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Director: Zhang Xianwei, MD Huazhong University of Science and Technology
More Information
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Responsible Party: Xianwei Zhang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01181492    
Other Study ID Numbers: HuazhongU
First Posted: August 13, 2010    Key Record Dates
Results First Posted: November 1, 2013
Last Update Posted: November 1, 2013
Last Verified: August 2013
Keywords provided by Xianwei Zhang, Huazhong University of Science and Technology:
gene polymorphism
CYP3A4
fentanyl
HPLC
Analgesics