PainNCT01181492
Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
An observational study of Pain and Surgery, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Apr 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 176 Chinese patients receiving elective lower abdominal surgery under general anesthesia
Who may be able to join
- Aged 20-65 years
- Anesthesiologists (ASA) physical status I or II;
- With ±20% of ideal body weight;
- Received PCA administration;
- Agreed to participate the research
Who cannot join
- History of chronic pain;
- Psychiatric diseases;
- Diabetes mellitus;
- Severe cardiovascular diseases;
- Kidney or liver diseases;
- Alcohol or drug abuse (according to the criteria of DSM-IV);
Show all 10Show fewer
- Pregnancy or at lactation period;
- Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;
- Refused PCA administration;
- Disagree to participate to the research
Trial locations and contacts
1 site in 1 country.
China1 site
1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.
- Keywords
- gene polymorphism, CYP3A4, fentanyl, HPLC, Analgesics
- Medical subject headings
- Pain
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 |
|---|---|---|
| *1/*1 | Grouped by CYP3A4*1G polymorphism, wild-type homozygote | |
| *1/*1G | Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote | |
| *1G/*1G | Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP3A4*1G Polymorphism
According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G
Measured: 48 hours after operation
Secondary outcomes (2)
The Visual Analog Scale 24 Hours Postoperative
The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation
Measured: 24 hours after operation
PCA Fentanyl Consumption
PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.
Measured: 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang, Huazhong University of Science and Technology
- Investigators
- Zhang Xianwei, MD, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181492
- Sponsor's protocol ID
- HuazhongU
- Status last verified
- Aug 2013
- First submitted
- 11 Aug 2010
- Last updated
- 1 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01181492
- Acronym / sponsor ID
- HuazhongU
- Keywords
- gene polymorphism, CYP3A4, fentanyl, HPLC, Analgesics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 1 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| *1/*1 | – | –Grouped by CYP3A4*1G polymorphism, wild-type homozygote |
| *1/*1G | – | –Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote |
| *1G/*1G | – | –Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 176 Chinese patients receiving elective lower abdominal surgery under general anesthesia
Key inclusion criteria (5 listed)
- Aged 20-65 years
- Anesthesiologists (ASA) physical status I or II;
- With ±20% of ideal body weight;
- Received PCA administration;
- Agreed to participate the research
Key exclusion criteria (10 listed)
- History of chronic pain;
- Psychiatric diseases;
- Diabetes mellitus;
- Severe cardiovascular diseases;
- Kidney or liver diseases;
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
CYP3A4*1G Polymorphism
Time frame: 48 hours after operation
According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G
2 secondary outcomes
The Visual Analog Scale 24 Hours Postoperative
Time frame: 24 hours after operation
PCA Fentanyl Consumption
Time frame: 24 h after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zhang Xianwei, 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 Pain and Surgery, run by Huazhong University of Science and Technology 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 5 inclusion and 10 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 Nov 2013. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CYP3A4*1G Polymorphism (time frame: 48 hours after operation). 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 Nov 2013.