Intranasal Insulin and Neurocognitive Function
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of intranasal insulin in resolving post-operative delirium
研究概览
简要总结
Post-operative delirium happens when patients wake up from anesthesia. Patients experiencing post-operative delirium are very confused, not being able to think or function "normally". These patients are hard to take care of and they tend to have more dementia as they age compared to patients who don't experience post-operative delirium. Intranasal insulin has been shown to reverse confusion associated with Alzheimer's disease (humans) and AIDS (mice).
Intranasal insulin has been safely administered to 1092 patients in 38 different studies. There were no cases of clinically low blood sugar and a few cases of mild nasal irritation that happened also with salt water when the subjects received multiple intranasal doses.
No one has tried to reverse post-operative delirium with intranasal insulin. The delirium associated with Alzheimer's Disease and AIDS have very similar symptoms and what happens in the brain is very similar also.
The investigators intent is to administer intranasal insulin to patients exhibiting post-operative delirium in order to reverse the symptoms because the investigators think that the three disease states are closely related and intranasal insulin has had some success in reversing the delirium in the other two disease states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The investigational pharmacist will use randomization software to randomize numbers 1-30. Each number will be randomized to either active drug (regular insulin) or placebo (normal saline).The investigational pharmacist will have the randomization table should un-blinding be required.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (>65 years of age) undergoing elective surgery using vapor anesthesia displaying post-operative delirium as defined by a CAM evaluation within time to PACU discharge post-surgery are eligible.
- •Those patients 65 and older undergoing surgery using vapor anesthesia, who are consented but do not exhibit delirium and are not part of the study are still considered recruited subjects, but are not in the active study.
排除标准
- •Patients with a history of severe dementia, anoxic brain injury, or neuromuscular disorders
- •Non-English-speaking patients
- •Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery
- •thiazolidinediones
- •hormones which may affect plasma glucose or insulin
- •contraceptive, diphenylhydantoin
- •patients with allergy to insulin
- •acromegaly
- •Cushing's syndrome
- •hyperthyroidism and pheochromocytoma
- •renal impairment
- •pregnant and lactating women
- •base line blood glucose < 3.9 mmol/L
研究组 & 干预措施
Treatment Group
The treatment group will receive 40 IU via four activations of an intranasal spray.
干预措施: Insulin (Drug)
Placebo Group
The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).
干预措施: Saline (Drug)
结局指标
主要结局
Efficacy of intranasal insulin in resolving post-operative delirium
时间窗: 6 hours post diagnosis
Measured by administering the Confusion Assessment Method tool
次要结局
- Length of stay in the post-anesthesia care unit (PACU)(Time from admission to the PACU until discharge from PACU, up to 18 hours from admission to the PACU)
研究者
Frank E Weinhold Pharm.D., M.S.
Principal Investigator
University of Kansas Medical Center