Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- respiratory rate
研究概览
简要总结
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease.
- •Aged 18-45 years
- •Body Mass Index 18-25kg/m2,body weight 40-65 kilograms
- •Agreed to participate the research
排除标准
- •Difficult airway
- •upper respiratory tract infection within 2 weeks
- •history of allergy or long-term use of propofol and opioids
- •self-rating anxiety scale before operation indicates anxiety
- •pregnancy or lactation.
结局指标
主要结局
respiratory rate
时间窗: 20 min after administration
Number of breaths per minute
CYP3A4*1G Polymorphism
时间窗: 1 week after operation
The patients were classified by genotype including wild-type homozygote (CYP3A4\*1/\*1, GG), mutant heterozygote (CYP3A4\*1/\*1G, GA), and mutant homozygote (CYP3A4\*1G/\*1G, AA).
bispectral index
时间窗: 20 min after administration
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
次要结局
未报告次要终点
研究者
Yanqi
Attending
Peking University People's Hospital