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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03869346

Enrollment

200

Registered

2019-03-11

Start date

2019-03-10

Completion date

2021-05-20

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fentanyl

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 Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation.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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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).

Countries

China

Contacts

Primary ContactQi Yan, MD

yanqi04@163.com13811319638

Backup ContactYi Feng, MD

yifeng65@163.com01088325581

Outcome results