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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| *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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| Measure | Description | Time Frame |
|---|---|---|
| CYP3A4*1G Polymorphism | According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G | 48 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PCA Fentanyl Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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176 Chinese patients receiving elective lower abdominal surgery under general anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Xianwei, MD | Huazhong University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | *1/*1 | Grouped by CYP3A4*1G polymorphism, wild-type homozygote |
| FG001 | *1/*1G | Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote |
| FG002 | *1G/*1G | Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | *1/*1 | Grouped by CYP3A4*1G polymorphism, wild-type homozygote |
| BG001 | *1/*1G | Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CYP3A4*1G Polymorphism | According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G | the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant. | Posted | Number | participants | 48 hours after operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | *1/*1 | Grouped by CYP3A4*1G polymorphism, wild-type homozygote |
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The preoperative and postoperative data were not all integrallty recorded in a relative short period and entered into Excel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhang Xianwei | Huazhong University of Science&Technology | 027 83662853 | ourpain@163.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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176 blood samples were extracted
PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery. |
| 24 h after surgery |
| BG002 | *1G/*1G | Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| *1G/*1G |
Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote |
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 24 hours after operation |
|
|
|
| Secondary | PCA Fentanyl Consumption | PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery. | Posted | Mean | Standard Deviation | μg | 24 h after surgery |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | *1/*1G | Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote | 0 | 66 | 0 | 66 |
| EG002 | *1G/*1G | Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote | 0 | 7 | 0 | 7 |
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