Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Confusion Assessment method for the ICU
研究概览
简要总结
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective open heart surgery requiring cardiopulmonary bypass
排除标准
- •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.
研究组 & 干预措施
Intranasal Insulin 40 IU
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
干预措施: Regular Insulin, Human 100 UNT/ML (Drug)
Intranasal Normal Saline
Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7
干预措施: Normal Saline Flush, 0.9% Injectable Solution (Drug)
结局指标
主要结局
Confusion Assessment method for the ICU
时间窗: Up to 7 days after surgery
Postoperative Delirium is assessment
Rey Auditory Verbal Leaning
时间窗: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 15
Rey-Osterrieth Complex Figure Test
时间窗: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 8
次要结局
- Stroop Test(up to 12 month)
- Trail Making Test(up to 12 month)
- Tower of London test(up to 12 month)
- Symbol Digit Modalities Test(up to 12 month)
- Boston Naming Test(up to 12 month)
- Clock Drawing Test(up to 12 month)
研究者
Hiroaki Sato, MD., PhD.
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre