Identification of Polymorphisms Involved in the Metabolism of Propofol

NCT ID: NCT02271542

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-30

Brief Summary

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Identification of Polymorphisms Involved in the Metabolism of Propofol

Detailed Description

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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

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UGT1A1*28 Polymorphism

Keywords

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Propofol Polymorphism UGT1A9 CYP2B6

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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between 1-10 ages

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.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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.

under 60 ages

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.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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.

upper 60 ages

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.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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.

Interventions

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propofol

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.

Intervention Type DRUG

Other Intervention Names

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pofol

Eligibility Criteria

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Inclusion Criteria

* Patients who used propofol for induction onl
* Between the ages of 1-85

Exclusion Criteria

* Patients taking drugs that may affect the metabolism of propofol (exp.Ketamine)
* Smoking and Alcohol users
* Patients using herbal medicines
Minimum Eligible Age

1 Year

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Ulgey

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil AKBULUT, Resident

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/215

Identifier Type: -

Identifier Source: org_study_id