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

August 11, 2010
December 29, 2011
November 2008
April 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01181492 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
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.

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Observational
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Non-Probability Sample

176 Chinese patients receiving elective lower abdominal surgery under general anesthesia

  • Pain
  • Surgery
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  • *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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01181492
HuazhongU
Yes
Not Provided
Huazhong University of Science and Technology
Janssen Research Council China
Not Provided
Huazhong University of Science and Technology
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP