Identification of Polymorphisms Involved in the Metabolism of Propofol

NCT02271542 | Completed Phase 4

• 1 other identifier: 2013/215
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Identification of Polymorphisms Involved in the Metabolism of Propofol

Conditions

UGT1A1*28 Polymorphism

Keywords

Propofol; Polymorphism; UGT1A9; CYP2B6

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes after induction

Study Arms (3)

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.

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.

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.

Drug: propofol

Interventions

propofol 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.

Also known as: pofol

between 1-10 ages; under 60 ages; upper 60 ages

Eligibility Criteria

• Age: 1 Year - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Halil AKBULUT, Resident

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 22, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)