SurgeryNCT02070614
Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption
An observational study of Surgery and Individuality, run by Xianwei Zhang at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery, Individuality
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 Chinese male and female patients receiving elective upper abdominal surgery (liver, pancreatic, gallbladder) under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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.
Read the 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
- Conditions
- Surgery, Individuality
- Keywords
- sufentanil, metabolism, cytochrome P450 3A4, gene polymorphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between rs2242480 polymorphism and sufentanil metabolism
according to rs2242480 genotype and plasma concentration of sufentanil
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 4 months
relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil
according to postoperative PCA sufentanil consumption and rs2242480 genotype
Measured: 4 months
relation between Visual Analogue Scale/Score(VAS) and rs2242480
according to PCA VAS and rs2242480 genotype
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xianwei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianwei Zhang, Huazhong University of Science and Technology
- Investigators
- Xianwei Zhang, MD, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070614
- Sponsor's protocol ID
- CYP3A4 and sufentanil
- Status last verified
- Aug 2015
- First submitted
- 23 Feb 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption
- ClinicalTrials.gov ID
- NCT02070614
- Acronym / sponsor ID
- CYP3A4 and sufentanil
- Conditions
- Surgery, Individuality
- Keywords
- sufentanil, metabolism, cytochrome P450 3A4, gene polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Xianwei ZhangUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 Chinese male and female patients receiving elective upper abdominal surgery (liver, pancreatic, gallbladder) under general anesthesia
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the correlation between rs2242480 polymorphism and sufentanil metabolism
Time frame: 4 months
according to rs2242480 genotype and plasma concentration of sufentanil
3 secondary outcomes
Variation of plasma concentration of sufentanil
Time frame: 4 months
relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil
Time frame: 4 months
relation between Visual Analogue Scale/Score(VAS) and rs2242480
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianwei Zhang, MD study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Individuality, run by Xianwei Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between rs2242480 polymorphism and sufentanil metabolism (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.