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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181492
• Other study ID #: HuazhongU
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: August 28, 2013
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2013
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Pain
• Surgery

Locations

Country	Name	City	State
China	1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan,	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CYP3A4*1G Polymorphism	According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G	48 hours after operation	Yes
Secondary	The Visual Analog Scale 24 Hours Postoperative	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	24 hours after operation	Yes
Secondary	PCA Fentanyl Consumption	PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.	24 h after surgery	Yes