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

NCT ID: NCT03869346

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-10

Study Completion Date

2021-05-20

Brief Summary

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 Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation.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

Detailed Description

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Conditions

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Fentanyl

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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GG

wild-type homozygote (CYP3A4\*1/\*1, GG)

No interventions assigned to this group

GA

mutant heterozygote (CYP3A4\*1/\*1G, GA),

No interventions assigned to this group

AA

mutant homozygote (CYP3A4\*1G/\*1G, AA)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yichang Humanwell Pharmaceutical Co., Ltd., China

INDUSTRY

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanqi

Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Feng, Professor

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Yan, MD

Role: CONTACT

13811319638

Yi Feng, MD

Role: CONTACT

01088325581

Facility Contacts

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qi yan

Role: primary

8613811319638

Other Identifiers

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NAOOP

Identifier Type: -

Identifier Source: org_study_id

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