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