Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
1 other identifier
observational
200
1 country
1
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 Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 10, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2021
CompletedSeptember 6, 2019
September 1, 2019
2 years
March 1, 2019
September 3, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
bispectral index
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
20 min after administration
respiratory rate
Number of breaths per minute
20 min after administration
CYP3A4*1G Polymorphism
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).
1 week after operation
Study Arms (3)
GG
wild-type homozygote (CYP3A4\*1/\*1, GG)
GA
mutant heterozygote (CYP3A4\*1/\*1G, GA),
AA
mutant homozygote (CYP3A4\*1G/\*1G, AA)
Eligibility Criteria
200 Chinese Han patients receiving elective surgery under general anesthesia
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Biospecimen
200 blood samples were withdrawn
Study Officials
- STUDY DIRECTOR
Yi Feng, Professor
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending
Study Record Dates
First Submitted
March 1, 2019
First Posted
March 11, 2019
Study Start
March 10, 2019
Primary Completion
March 10, 2021
Study Completion
May 20, 2021
Last Updated
September 6, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share