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

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ClinicalTrials.gov Identifier: NCT03869346
Recruitment Status : Unknown
Verified September 2019 by Yanqi, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 11, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Yichang Humanwell Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
Yanqi, Peking University People's Hospital

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 Venous blood was withdrawn for genotyping of CYP3A4*1G before operation.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

Condition or disease
Fentanyl

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : May 20, 2021
Groups and Cohorts
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Group/Cohort
GG
wild-type homozygote (CYP3A4*1/*1, GG)
GA
mutant heterozygote (CYP3A4*1/*1G, GA),
AA
mutant homozygote (CYP3A4*1G/*1G, AA)


Outcome Measures
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Primary Outcome Measures :
  1. bispectral index [ Time Frame: 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

  2. respiratory rate [ Time Frame: 20 min after administration ]
    Number of breaths per minute

  3. CYP3A4*1G Polymorphism [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
200 blood samples were withdrawn

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 Chinese Han patients receiving elective surgery under general anesthesia
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869346


Contacts
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Contact: Qi Yan, MD 13811319638 yanqi04@163.com
Contact: Yi Feng, MD 01088325581 yifeng65@163.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: qi yan    8613811319638    yanqi04@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Yichang Humanwell Pharmaceutical Co.,Ltd
Investigators
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Study Director: Yi Feng, Professor Peking University People's Hospital
More Information
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Responsible Party: Yanqi, Attending, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03869346    
Other Study ID Numbers: NAOOP
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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