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临床试验/NCT07543523
NCT07543523进行中(未招募)不适用

The Influence of Genetic Polymorphism on Dose- Dependent Analgesic Response and Safety to Propofol in General Anesthesia

Superior University1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
159
试验地点
1
主要终点
Propofol therapeutic outcomes

研究概览

简要总结

This study investigates the influence of genetic polymorphisms in key drug-metabolizing enzymes-CYP2B6, CYP2C9, and UGT1A9-on the individual response to propofol, a widely used intravenous anesthetic, in patients undergoing general anesthesia. Despite propofol's fast onset and favorable recovery profile, significant inter-individual variability exists in its dosing requirements, sedation depth, and adverse effects. Such variability is believed to arise in part from genetic differences that affect drug metabolism and action. This research focuses on identifying how specific gene variants, particularly those linked to poor or altered metabolizer phenotypes, influence clinical outcomes like induction time, recovery time, and safety profiles during anesthesia.

详细描述

Focusing on the Pakistani population, this research seeks to fill a gap in regional pharmacogenetic data, which is limited but critical for optimizing patient care. By identifying associations between genetic profiles and anesthetic responses, the findings could support the development of personalized anesthesia protocols, improving drug safety and effectiveness. This project has great potential to advance precision medicine in anesthesiology by enabling more personalized therapeutic strategies that are guided by each patient's distinct genetic makeup.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female & males aged 18-60yrs
  • ASA grade 1 & II
  • Patient enrolled for elective surgery

排除标准

  • History of drug allergies
  • Any chronic disease such as hepatic, psychiatric & kidney disease.
  • History of drug intake (opioids, analgesics)
  • History of smoking, alcohol or drug addiction.

研究组 & 干预措施

Isoflurane Group

Experimental

干预措施: Isoflurane Group (Combination Product)

Propofol Group

Active Comparator

干预措施: Propofol Group (Diagnostic Test)

结局指标

主要结局

Propofol therapeutic outcomes

时间窗: 24 Months

Produces prompt hypnosis (within 40 seconds) and allows for rapid awakening upon discontinuation (10-30 min)

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

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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