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Completed

NCT Number: NCT02070614

Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the correlation between rs2242480 polymorphism and sufentanil metabolism

    Time frame: 4 months

    according to rs2242480 genotype and plasma concentration of sufentanil

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Xianwei Zhang

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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