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

Fentanyl Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869346
• Other study ID #: NAOOP
• Status: Recruiting
• Start date: March 10, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: September 2019
• Source: Peking University People's Hospital
• Contact: Qi Yan, MD
• Phone: 13811319638
• Email: yanqi04[@]163.com
• Is FDA regulated: No
• Study type: Observational

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 Venous blood was withdrawn for genotyping of CYP3A4*1G before operation.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 20, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Grade?-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.

Related Conditions & MeSH terms

• Fentanyl

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Yichang Humanwell Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	respiratory rate	Number of breaths per minute	20 min after administration
Primary	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