Identification of Polymorphisms Involved in the Metabolism of Propofol

October 17, 2017 updated by: Ayse Ulgey, TC Erciyes University
Identification of Polymorphisms Involved in the Metabolism of Propofol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • pofol
Experimental: 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.
Drug: 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.
Other Names:
  • pofol
Experimental: 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.
Drug: 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.
Other Names:
  • pofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Halil AKBULUT, Resident, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 19, 2014

First Submitted That Met QC Criteria

October 19, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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