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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01181492
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

Purpose: This study aimed to investigate the impact of CYP3A41G 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 CYP3A41G 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 or Disease	Intervention/Treatment	Phase
Pain; Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 176 participants
• Official Title: Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
*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

Outcome Measures

Primary Outcome Measures

1. CYP3A4*1G Polymorphism [48 hours after operation]

   According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G

Secondary Outcome Measures

1. The Visual Analog Scale 24 Hours Postoperative [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 [24 h after surgery]

   PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

• Study Director: Zhang Xianwei, MD, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xianwei Zhang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT01181492
• Other Study ID Numbers: HuazhongU
• First Posted: Aug 13, 2010
• Last Update Posted: Nov 1, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Xianwei Zhang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology: gene polymorphism; CYP3A4; fentanyl; HPLC; Analgesics

Study Results

Participant Flow

Recruitment Details	In Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, from November 2008 to April 2010 a total of 176 patients were recruited in this study precedure.

Arm/Group Title	*1/*1	*1/*1G	*1G/*1G
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote	Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote	Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
Period Title: Overall Study
STARTED	103	66	7
COMPLETED	103	66	7
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	*1/*1	*1/*1G	*1G/*1G	Total
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote	Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote	Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote	Total of all reporting groups
Overall Participants	103	66	7	176
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	103 100%	66 100%	7 100%	176 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.5 (11.7)	47.1 (10.1)	42.3 (7.8)	45.9 (11.1)
Sex: Female, Male (Count of Participants)
Female	55 53.4%	34 51.5%	4 57.1%	93 52.8%
Male	48 46.6%	32 48.5%	3 42.9%	83 47.2%
Region of Enrollment (participants) [Number]
China	103 100%	66 100%	7 100%	176 100%

Outcome Measures

1. Primary Outcome

Title	CYP3A4*1G Polymorphism
Description	According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G
Time Frame	48 hours after operation

Outcome Measure Data

Analysis Population Description

the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant.

Arm/Group Title	*1/*1	*1/*1G	*1G/*1G
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote	Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote	Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
Measure Participants	103	66	7
Number [participants]	103 100%	66 100%	7 100%

2. Secondary Outcome

Title	The Visual Analog Scale 24 Hours Postoperative
Description	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
Time Frame	24 hours after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	*1/*1	*1/*1G	*1G/*1G
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote	Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote	Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
Measure Participants	103	66	7
Mean (Standard Deviation) [units on a scale]	3.7 (1.3)	3.7 (1.1)	3.4 (1.3)

3. Secondary Outcome

Title	PCA Fentanyl Consumption
Description	PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.
Time Frame	24 h after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	*1/*1	*1/*1G	*1G/*1G
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote	Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote	Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
Measure Participants	103	66	7
Mean (Standard Deviation) [μg]	395.0 (138.5)	359.8 (120.2)	247.1 (73.2)

Adverse Events

Arm/Group Title	*1/*1		*1/*1G		*1G/*1G
Arm/Group Description	Grouped by CYP3A4*1G polymorphism, wild-type homozygote		Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote		Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
All Cause Mortality
	*1/*1		*1/*1G		*1G/*1G
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	*1/*1		*1/*1G		*1G/*1G
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/66 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	*1/*1		*1/*1G		*1G/*1G
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/66 (0%)		0/7 (0%)

Limitations/Caveats

The preoperative and postoperative data were not all integrallty recorded in a relative short period and entered into Excel.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.