Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption

NCT02070614 | Completed DMC

• 1 other identifier: CYP3A4 and sufentanil
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Individuality

Keywords

sufentanil; metabolism; cytochrome P450 3A4; gene polymorphism

Outcome Measures

Primary Outcomes (1)

• the correlation between rs2242480 polymorphism and sufentanil metabolism

  according to rs2242480 genotype and plasma concentration of sufentanil

  4 months

Secondary Outcomes (3)

• Variation of plasma concentration of sufentanil

  4 months

• relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil

  4 months

• relation between Visual Analogue Scale/Score(VAS) and rs2242480

  4 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 Chinese male and female patients receiving elective upper abdominal surgery (liver, pancreatic, gallbladder) under general anesthesia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xianwei Zhang: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

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).

Study Officials

• Xianwei Zhang, MD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 23, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CN (1)