Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- CYP3A4*1G Polymorphism
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
CYP3A4*1G Polymorphism
时间窗: 48 hours after operation
According to CYP3A4\*1G polymorphism,patients are devided into three groups: \*1/\*1,\*1/\*1G,\*1G/\*1G
次要结局
- The Visual Analog Scale 24 Hours Postoperative(24 hours after operation)
- PCA Fentanyl Consumption(24 h after surgery)
研究者
Xianwei Zhang
Tongji Hospital, Tongji Medical College
Huazhong University of Science and Technology