Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients

Peking University

Status: Unknown

Conditions: Fentanyl

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03869346

NAOOP

Details and patient eligibility

About

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 Venous blood was withdrawn for genotyping of CYP3A4*1G before operation.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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

200 participants in 3 patient groups

GG

Description:

wild-type homozygote (CYP3A4\*1/\*1, GG)

GA

Description:

mutant heterozygote (CYP3A4\*1/\*1G, GA),

AA

Description:

mutant homozygote (CYP3A4\*1G/\*1G, AA)