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临床试验/NCT01121497
NCT01121497Unknown不适用

The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Cognitive functioning assessed by standard neuropsychological tests

研究概览

简要总结

The purpose of this study is to determine whether the administration of physostigmine in combination with sedation for colonoscopy can minimize the cognitive decline at the time of hospital discharge

详细描述

Physostigmine, a tertiary cholinesterase inhibitor, which prevents the breakdown of ACh by inhibiting the enzyme acetylcholinesterase (AChE), crosses the blood-brain barrier (BBB), and elevates brain ACh levels. Physostigmine has been shown to improve attention, and performance in working memory. It has also been shown to produce analgesia following systemic or central administration.

Patients undergoing colonoscopy under sedation of propofol and fentanyl show cognitive decline in the immediate period following the procedure. In this study, half the patients will receive physostigmine in combination with the sedation, and their cognitive functioning at the time of hospital discharge will be assessed by standard neuropsychological tests, and compared to that of patients without physostigmine.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Over18 years old
  • •ASA I-III
  • •Fluency in Hebrew, Russian, or Arabic
  • •Absence of serious hearing or vision impairment

排除标准

  • •History of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants
  • •Heart failure (NYHA > 3)
  • •Liver failure
  • •Respiratory problems (asthma, etc.)

研究组 & 干预措施

Physostigmine

Experimental

Colonoscopy sedation with or without physostigmine

干预措施: Physostigmine (Drug)

结局指标

主要结局

Cognitive functioning assessed by standard neuropsychological tests

时间窗: At time of hospital discharge following colonoscopy procedure

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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