Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

Surgery Clinical Trial

Official title:

Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070614
• Other study ID #: CYP3A4 and sufentanil
• Status: Completed
• Phase: N/A
• First received: February 23, 2014
• Last updated: August 30, 2015
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study was designed for exploring the association of cytochrome P450 3A4 rs2242480 polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal surgery，to provide evidence for genetic prediction of personalized medication.Methods:60 patients who prepared for elective upper abdominal surgery under general anesthesia were recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480 genotyping was carried out by direct sequencing. The blood samples were drawn before anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil concentration detection with high performance liquid chromatography-mass spectrometry (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil concentration and PCA sufentanil consumption were analyzed to investigate the differences among rs2242480 three genotypes.

Description:

The study consisted of healthy men and women between 18 to 65 years of age.

Participants were screened and stratified according to cytochrome P450 3A4 rs2242480 genotype:

• 1/*1 Grouped by rs2242480 polymorphism, wild-type homozygote

• 1/*1G Grouped by rs2242480 polymorphism,*1/*1G: mutant heterozygote

• 1G/*1G Grouped by rs2242480 polymorphism,*1G/*1G: mutant homozygote

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1.American Society of Anesthesiologists (ASA) physical status I or II 2.age from 18 to 65 years old 3.BMI of 19~26kg/m2

Exclusion Criteria:

• 1.known history of chronic pain, psychiatric diseases, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function 2.alcohol or drug abuse (according to the criteria of Diagnostic and Statistical Manual of Mental Disorders-IV) 3.pregnancy or at lactation period 4.Patients who consumed drugs (1 week) or foods (3 days) known to inhibit or induce the expression of cytochrome P450 3A4 enzymes prior to surgery were also excluded. The following drugs or foods included but were not limited to erythromycin, clarithromycin, alcohol, chocolate, coffee, grapefruit juice, verapamil, rifampicin, HIV protease inhibitors, phenytoin,itraconazole, dexamethasone, phenobarbital, and carbamazepine.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Individuality
• Surgery

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xianwei Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the correlation between rs2242480 polymorphism and sufentanil metabolism	according to rs2242480 genotype and plasma concentration of sufentanil	4 months	Yes
Secondary	Variation of plasma concentration of sufentanil	the single-dose sufentanil plasma concentration varies between participants, and the differences among 3 time-points is related with personal genotype.	4 months	Yes
Secondary	relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil	according to postoperative PCA sufentanil consumption and rs2242480 genotype	4 months	Yes
Secondary	relation between Visual Analogue Scale/Score(VAS) and rs2242480	according to PCA VAS and rs2242480 genotype	4 months	Yes