Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- the correlation between rs2242480 polymorphism and sufentanil metabolism
研究概览
简要总结
This study was designed for exploring the association of cytochrome P450 3A4 rs2242480 polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal surgery，to provide evidence for genetic prediction of personalized medication.Methods:60 patients who prepared for elective upper abdominal surgery under general anesthesia were recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480 genotyping was carried out by direct sequencing. The blood samples were drawn before anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil concentration detection with high performance liquid chromatography-mass spectrometry (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil concentration and PCA sufentanil consumption were analyzed to investigate the differences among rs2242480 three genotypes.
详细描述
The study consisted of healthy men and women between 18 to 65 years of age.
Participants were screened and stratified according to cytochrome P450 3A4 rs2242480 genotype:
- 1/*1 Grouped by rs2242480 polymorphism, wild-type homozygote
- 1/*1G Grouped by rs2242480 polymorphism,*1/*1G: mutant heterozygote
- 1G/*1G Grouped by rs2242480 polymorphism,*1G/*1G: mutant homozygote
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.American Society of Anesthesiologists (ASA) physical status I or II 2.age from 18 to 65 years old 3.BMI of 19～26kg/m2
排除标准
- •1.known history of chronic pain, psychiatric diseases, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function 2.alcohol or drug abuse (according to the criteria of Diagnostic and Statistical Manual of Mental Disorders-IV) 3.pregnancy or at lactation period 4.Patients who consumed drugs (1 week) or foods (3 days) known to inhibit or induce the expression of cytochrome P450 3A4 enzymes prior to surgery were also excluded. The following drugs or foods included but were not limited to erythromycin, clarithromycin, alcohol, chocolate, coffee, grapefruit juice, verapamil, rifampicin, HIV protease inhibitors, phenytoin,itraconazole, dexamethasone, phenobarbital, and carbamazepine.
结局指标
主要结局
the correlation between rs2242480 polymorphism and sufentanil metabolism
时间窗: 4 months
according to rs2242480 genotype and plasma concentration of sufentanil
次要结局
- Variation of plasma concentration of sufentanil(4 months)
- relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil(4 months)
- relation between Visual Analogue Scale/Score(VAS) and rs2242480(4 months)
研究者
Xianwei Zhang
Clinical Professor
Huazhong University of Science and Technology