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

• Conditions: Fentanyl

• Registration Number: NCT03869346
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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 Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation.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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-06
• Study Start: 2019-03-10
• Study First Posted: 2019-03-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06
• Primary Completion: 2021-03-10
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
respiratory rate	20 min after administration	Number of breaths per minute
CYP3A4*1G Polymorphism	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	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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China