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Completed

NCT Number: NCT01181492

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2010
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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