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

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Surgery
Pain

Study type

Observational

Funder types

Other

Identifiers

NCT01181492
HuazhongU

Details and patient eligibility

About

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.

Enrollment

176 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

176 participants in 3 patient groups

*1/*1
Description:
Grouped by CYP3A4\*1G polymorphism, wild-type homozygote
*1/*1G
Description:
Grouped by CYP3A4\*1G polymorphism,\*1/\*1G: mutant heterozygote
*1G/*1G
Description:
Grouped by CYP3A4\*1G polymorphism,\*1G/\*1G: mutant homozygote

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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