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临床试验/NCT02271542
NCT02271542已完成4 期

Identification of Polymorphisms Involved in the Metabolism of Propofol

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
300
试验地点
1
主要终点
Polymorphism

研究概览

简要总结

Identification of Polymorphisms Involved in the Metabolism of Propofol

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: propofol (Drug)

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.

干预措施: propofol (Drug)

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.

干预措施: propofol (Drug)

结局指标

主要结局

Polymorphism

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Ulgey

Resident

TC Erciyes University

研究点 (1)

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