Effect of Intranasal Insulin on POCD and POD
Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).
Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.
This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Thomas Schricker, M.D., PhD.
- 电话号码：5149341934
- 邮箱：thomas.schricker@mcgill.ca
研究联系人备份
- 姓名：Hiroaki Sato, M.D., PhD.
- 电话号码：5149341934
- 邮箱：hiroaki.sato2@mcgill.ca
学习地点
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Quebec
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Montreal、Quebec、加拿大、H4A3J1
- Royal Victoria Hospital McGill University Health Centre
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接触：
- Hiroaki Sato, M.D.PhD
- 电话号码：64275 5149341934
- 邮箱：tamaki.sato@muhc.mcgill.ca
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首席研究员：
- Hiroaki Sato, M.D.PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
•elective open heart surgery requiring cardiopulmonary bypass
Exclusion Criteria:
- inability to provide informed consent
- allergy to insulin
- pregnancy
- mother tongue other than English or French
- visual or hearing impairment interfering with the ability to complete cognitive tests.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intranasal Insulin 40 IU
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
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40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
其他名称：
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安慰剂比较：Intranasal Normal Saline
Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7
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Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rey Auditory Verbal Leaning
大体时间：up to 12 month
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Episodic Memory Lowest score: 0 Highest Score: 15
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up to 12 month
|
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Confusion Assessment method for the ICU
大体时间：Up to 7 days after surgery
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Postoperative Delirium is assessment
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Up to 7 days after surgery
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Rey-Osterrieth Complex Figure Test
大体时间：up to 12 month
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Episodic Memory Lowest score: 0 Highest Score: 8
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up to 12 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Trail Making Test
大体时间：up to 12 month
|
Executive Function
|
up to 12 month
|
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Tower of London test
大体时间：up to 12 month
|
Executive Function
|
up to 12 month
|
|
Symbol Digit Modalities Test
大体时间：up to 12 month
|
Information Processing Speed
|
up to 12 month
|
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Boston Naming Test
大体时间：up to 12 month
|
Language Lowest score: 0 Highest score: 60
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up to 12 month
|
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Clock Drawing Test
大体时间：up to 12 month
|
Visuospatial Function Lowest score: 1 Highest score: 10
|
up to 12 month
|
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Stroop Test
大体时间：up to 12 month
|
Executive Function
|
up to 12 month
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Regular Insulin, Human 100 UNT/ML的临床试验
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Centre for Addiction and Mental HealthUniversity Health Network, Toronto招聘中