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A clinical trial to study the relationship between CYP3A4, CYP3A5 gene polymorphism sites and sufentanil metabolism using a gene polymorphism detection kit (PCR-fluorescent probe method)

A clinical trial to study the relationship between CYP3A4, CYP3A5 gene polymorphism sites and sufentanil metabolism using a gene polymorphism detection kit (PCR-fluorescent probe method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097985
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Group 1: CYP3A4 wild type and CYP3A5 wild type (CCAA):None
Group 2: CYP3A4 heterozygous mutation and CYP3A5 wild type (CTAA):None
Group 3: CYP3A4 homozygous mutation and CYP3A5 wild type (TTAA):None
Group 4: CYP3A4 wild type and CYP3A5 Heterozygous mutant (CCAG):None
Group 5: CYP3A4 heterozygous mutation and CYP3A5 heterozygous mutant (CTAG):None
Group 6: CYP3A4 homozygous mutation and CYP3A5 heterozygous mutant (CTAG):None
Group 7: CYP3A4 wild type and CYP3A5 homozygous mutant (CCGG):None
Group 8: CYP3A4 heterozygous mutation and CYP3A5 homozygous mutant (CTGG):None
Group 9: CYP3A4 homozygous mutation and CYP3A5 homozygous mutant (TTGG):None

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Male or female aged 18-60 years; 2. ASA (American Society of Anesthesiologists) grade I-III, liver function child-Pugh grade A; 3. BMI 18-28; 4. Laparoscopic gastrointestinal or urinary surgeries, thoracoscopic esophageal and lung surgeries, or neurosurgical surgeries are planned to be performed under general anesthesia, and the anesthesia surgery can be administered stably and continuously for more than 120 minutes.

Exclusion criteria

Exclusion criteria: 1. Preoperative combination with severe cardiopulmonary vascular disease, diabetes mellitus, severe liver and/or renal dysfunction; 2. Preoperative history of chronic pain and psychiatric history; 3. Preoperative hypovolemia or hypotension; 4. History of fentanyl drug allergy and drug abuse; 5. Alcoholism, drug abuse or long-term use of painkillers; 6. Pregnant and lactating women; 7. Have taken drugs or foods that can inhibit or induce the expression of CYP3A enzyme within 1 week before surgery; 8. Those who have used monoammonia oxidase inhibitors within 2 weeks before surgery; 9. Other conditions that the investigator considers inappropriate to participate in clinical studies.

Design outcomes

Primary

MeasureTime frame
Changes in blood drug concentration before and after stopping continuous infusion of sufentanil for 2 hours;Pharmacokinetic parameters of sufentanil after continuous infusion for 2 hours and discontinuation;

Secondary

MeasureTime frame
CYP3A4 genotype;CYP3A5 genotype;

Countries

China

Contacts

Public ContactJianteng Gu

The First Affiliated Hospital (Southwest Hospital) of Army Medical University

jiantenggu@tmmu.edu.cn+86 139 8371 6009

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026