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

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 Venous blood was withdrawn for genotyping of CYP3A4*1G before operation.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

Study Overview

• Status: Unknown
• Conditions: Fentanyl

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: qi yan; Phone Number: 8613811319638; Email: yanqi04@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

200 Chinese Han patients receiving elective surgery under general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
GG; wild-type homozygote (CYP3A4*1/*1, GG)
GA; mutant heterozygote (CYP3A4*1/*1G, GA),
AA; mutant homozygote (CYP3A4*1G/*1G, AA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China
• Investigators: Study Director: Yi Feng, Professor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2019
• Primary Completion (Anticipated): March 10, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NAOOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No