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

This study has been completed.
Sponsor:
Collaborator:
Janssen Research Council China
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01181492
First received: August 11, 2010
Last updated: December 29, 2011
Last verified: April 2010
History of Changes
  Purpose

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
Pain
Surgery

Study Type: Observational
Official Title: Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • CYP3A4*1G polymorphism [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G

  • Plasma concentration of fentanyl [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
    Plasma concentration of fentanyl may related to the metabolism of fentanyl


Secondary Outcome Measures:
  • The visual analog scale 24 hours postoperative [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation

  • PCA fentanyl consumption [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.

  • The correlation between plasma fentanyl concentration and PCA fentanyl consumption [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
*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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181492

Locations
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
Janssen Research Council China
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01181492     History of Changes
Other Study ID Numbers: HuazhongU
Study First Received: August 11, 2010
Last Updated: December 29, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
gene polymorphism
CYP3A4
fentanyl
HPLC
Analgesics

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013