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Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

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ClinicalTrials.gov Identifier: NCT02070614
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology

Brief 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.

Condition or disease
Surgery Individuality

Detailed 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

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Official Title: Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption
Study Start Date : December 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Group/Cohort
rs2242480 wild-type homozygote
*1/*1 Grouped by rs2242480 polymorphism genotyping
rs2242480 mutant heterozygote
*1/*1G Grouped by rs2242480 polymorphism genotyping
rs2242480 mutant homozygote
*1G/*1G Grouped by rs2242480 polymorphism genotyping



Primary Outcome Measures :
  1. the correlation between rs2242480 polymorphism and sufentanil metabolism [ Time Frame: 4 months ]
    according to rs2242480 genotype and plasma concentration of sufentanil


Secondary Outcome Measures :
  1. Variation of plasma concentration of sufentanil [ Time Frame: 4 months ]
    the single-dose sufentanil plasma concentration varies between participants, and the differences among 3 time-points is related with personal genotype.

  2. relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil [ Time Frame: 4 months ]
    according to postoperative PCA sufentanil consumption and rs2242480 genotype

  3. relation between Visual Analogue Scale/Score(VAS) and rs2242480 [ Time Frame: 4 months ]
    according to PCA VAS and rs2242480 genotype


Biospecimen Retention:   Samples With DNA
The blood samples were drawn before anesthesia,30 min and 45min after anesthesia respectively,used for genotyping and plasma sufentanil concentration detection with high performance liquid chromatography-mass spectrometry (HPLC-MS).


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 Chinese male and female patients receiving elective upper abdominal surgery (liver, pancreatic, gallbladder) under general anesthesia
Criteria

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.

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): NCT02070614


Locations
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China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Xianwei Zhang
Investigators
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Study Director: Xianwei Zhang, MD Huazhong University of Science and Technology
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Responsible Party: Xianwei Zhang, Clinical Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02070614    
Other Study ID Numbers: CYP3A4 and sufentanil
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Xianwei Zhang, Huazhong University of Science and Technology:
sufentanil
metabolism
cytochrome P450 3A4
gene polymorphism