Pain, Surgery
Conditions
Keywords
gene polymorphism, CYP3A4, fentanyl, HPLC, Analgesics
Brief 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.
Interventions
None listed
Sponsors
Huazhong University of Science and Technology
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| PCA Fentanyl Consumption | 24 h after surgery | PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery. |
Countries
China
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.
Participants by arm
| Arm | Count |
|---|---|
| *1/*1 Grouped by CYP3A4\*1G polymorphism, wild-type homozygote | 103 |
| *1/*1G Grouped by CYP3A4\*1G polymorphism,\*1/\*1G: mutant heterozygote | 66 |
| *1G/*1G Grouped by CYP3A4\*1G polymorphism,\*1G/\*1G: mutant homozygote | 7 |
| Total | 176 |
Baseline characteristics
| Characteristic | *1/*1G | *1G/*1G | Total | *1/*1 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 7 Participants | 176 Participants | 103 Participants |
| Age Continuous | 47.1 years STANDARD_DEVIATION 10.1 | 42.3 years STANDARD_DEVIATION 7.8 | 45.9 years STANDARD_DEVIATION 11.1 | 45.5 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment China | 66 participants | 7 participants | 176 participants | 103 participants |
| Sex: Female, Male Female | 34 Participants | 4 Participants | 93 Participants | 55 Participants |
| Sex: Female, Male Male | 32 Participants | 3 Participants | 83 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 66 | 0 / 7 |
| serious Total, serious adverse events | 0 / 103 | 0 / 66 | 0 / 7 |
Outcome results
Primary
CYP3A4*1G Polymorphism
According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G
Time frame: 48 hours after operation
Population: the number of participants for analysis was determined according to gene type of CYP3A4\*1G polymorphism which was carried by participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| *1/*1 | CYP3A4*1G Polymorphism | 103 participants |
| *1/*1G | CYP3A4*1G Polymorphism | 66 participants |
| *1G/*1G | CYP3A4*1G Polymorphism | 7 participants |
Secondary
PCA Fentanyl Consumption
PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.
Time frame: 24 h after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| *1/*1 | PCA Fentanyl Consumption | 395.0 μg | Standard Deviation 138.5 |
| *1/*1G | PCA Fentanyl Consumption | 359.8 μg | Standard Deviation 120.2 |
| *1G/*1G | PCA Fentanyl Consumption | 247.1 μg | Standard Deviation 73.2 |
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
Time frame: 24 hours after operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| *1/*1 | The Visual Analog Scale 24 Hours Postoperative | 3.7 units on a scale | Standard Deviation 1.3 |
| *1/*1G | The Visual Analog Scale 24 Hours Postoperative | 3.7 units on a scale | Standard Deviation 1.1 |
| *1G/*1G | The Visual Analog Scale 24 Hours Postoperative | 3.4 units on a scale | Standard Deviation 1.3 |