UGT1A1*28 PolymorphismPhase 4NCT02271542
Identification of Polymorphisms Involved in the Metabolism of Propofol
A Phase 4 study testing propofol in people with UGT1A1*28 Polymorphism, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Identification of Polymorphisms Involved in the Metabolism of Propofol Read more about this study
- Who is it for?
- Ages 1 year to 85 years
- Conditions the study is for
- UGT1A1*28 Polymorphism
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to Apr 2016
- Phase
- Phase 4
- 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 1 year to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who used propofol for induction onl
- Between the ages of 1-85
Who cannot join
- Patients taking drugs that may affect the metabolism of propofol (exp.Ketamine)
- Smoking and Alcohol users
- Patients using herbal medicines
Trial locations and contacts
1 site in 1 country.
About this study
Identification of Polymorphisms Involved in the Metabolism of Propofol
Read the detailed description
Propofol inside and outside the operating room during anesthesia is a drug widely used. In terms of efficacy and side effect profile of propofol knows if properties are insufficient data on the metabolism. Propofol typically undergoes biotransformation by microsomal enzymes in the liver. For most of the administered dose, takes place glucuronidation by UGT1A9 enzyme, while the remaining portion is oxidized with CYP2B6 hydroxylation reactions. However, these enzymes are involved in the metabolism of propofol are enzymes highly polymorphic. Polymorphisms occurring in these enzymes; the effects of propofol, side effects and drug needs to show individual differences in terms of causes. Determination of the genetic background of individuals and personal anesthetic regimen improved. Thus, useful person drug resistance, increased incidence of side effects can be reduced. In particular, be aware of some mutations, such as propofol infusion syndrome mortal side effects can be prevented. The main purpose of this study, these individual differences are thought to be the cause of polymorphic variation in UGT1A9 and CYP2B6 gene to determine. Especially in the UGT1A9 gene mutations that may be associated with ethnic structure can be observed. In Caucasian, African-American communities and polymorphisms of this gene has been shown in Japanese. So all of them as a result of the genetic structure of any society can be considered as its own. Therefore, this study aimed to determine the genetic polymorphism of Turkish society has.Physiological factors such as age and sex between persons of different answers to the causes of propofol. Another object of this study was the identification of these factors can lead to different answers which is to present the relationship between polymorphisms.
- Conditions
- UGT1A1*28 Polymorphism
- Being tested
- propofol
- Keywords
- Propofol, Polymorphism, UGT1A9, CYP2B6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called pofol
Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed.
| Study group | Role | What they receive |
|---|---|---|
| between 1-10 ages | Experimental | Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. Receives: Drug: propofol |
| under 60 ages | Experimental | Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. Receives: Drug: propofol |
| upper 60 ages | Experimental | Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphism
EDTA blood samples from patients for the study of polymorphisms, DNA will be obtained with the help of DNA isolation kit. DNA isolation from blood samples taken after the sample is stored at -80 ° C until the operating phase.
Research priorities included in the appropriate primers for each polymorphism will be created.
Using appropriate PCR program, will be determined the genotype of each polymorphism.
Measured: 60 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UGT1A1*28 PolymorphismStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- Halil AKBULUT, Resident, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271542
- Sponsor's protocol ID
- 2013/215
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Polymorphisms Involved in the Metabolism of Propofol
- ClinicalTrials.gov ID
- NCT02271542
- Acronym / sponsor ID
- 2013/215
- Conditions
- UGT1A1*28 Polymorphism
- Keywords
- Propofol, Polymorphism, UGT1A9, CYP2B6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Oct 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.
Identification of Polymorphisms Involved in the Metabolism of Propofol
Detailed description
Propofol inside and outside the operating room during anesthesia is a drug widely used. In terms of efficacy and side effect profile of propofol knows if properties are insufficient data on the metabolism. Propofol typically undergoes biotransformation by microsomal enzymes in the liver. For most of the administered dose, takes place glucuronidation by UGT1A9 enzyme, while the remaining portion is oxidized with CYP2B6 hydroxylation reactions. However, these enzymes are involved in the metabolism of propofol are enzymes highly polymorphic. Polymorphisms occurring in these enzymes; the effects of propofol, side effects and drug needs to show individual differences in terms of causes. Determination of the genetic background of individuals and personal anesthetic regimen improved. Thus, useful person drug resistance, increased incidence of side effects can be reduced. In particular, be aware of some mutations, such as propofol infusion syndrome mortal side effects can be prevented. The main purpose of this study, these individual differences are thought to be the cause of polymorphic variation in UGT1A9 and CYP2B6 gene to determine. Especially in the UGT1A9 gene mutations that may be associated with ethnic structure can be observed. In Caucasian, African-American communities and polymorphisms of this gene has been shown in Japanese. So all of them as a result of the genetic structure of any society can be considered as its own. Therefore, this study aimed to determine the genetic polymorphism of Turkish society has.Physiological factors such as age and sex between persons of different answers to the causes of propofol. Another object of this study was the identification of these factors can lead to different answers which is to present the relationship between polymorphisms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| between 1-10 ages | Experimental | Drug: propofolPropofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. |
| under 60 ages | Experimental | Drug: propofolPropofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. |
| upper 60 ages | Experimental | Drug: propofolPropofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who used propofol for induction onl
- Between the ages of 1-85
Key exclusion criteria (3 listed)
- Patients taking drugs that may affect the metabolism of propofol (exp.Ketamine)
- Smoking and Alcohol users
- Patients using herbal medicines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: pofolPropofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed. | Drug | between 1-10 ages, under 60 ages, upper 60 ages |
Primary outcome
Polymorphism
Time frame: 60 minutes after induction
EDTA blood samples from patients for the study of polymorphisms, DNA will be obtained with the help of DNA isolation kit. DNA isolation from blood samples taken after the sample is stored at -80 ° C until the operating phase. Research priorities included in the appropriate primers for each polymorphism will be created. Using appropriate PCR program, will be determined the genotype of each polymorphism.
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 18 Oct 2017.
- Individual participant dataSharing planned: No
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.
Halil AKBULUT, Resident principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol in people with UGT1A1*28 Polymorphism, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 18 Oct 2017. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Polymorphism (time frame: 60 minutes after induction). 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 18 Oct 2017.