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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin 40 IU | Experimental | 40 IU of Humulin-R via nose Before surgery and everyday after surgery up to POD 7 |
|
| Intranasal Normal Saline | Placebo Comparator | Normal Saline via nose Before surgery and everyday after surgery up to POD 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular insulin | Drug | 40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confusion Assessment method for the ICU | Post Operative Delirium | an average of 5 days |
| Rey Auditory Verbal Leaning | Episodic Memory Lowest score: 0 Highest Score: 15 | up to 12 month |
| Rey-Osterrieth Complex Figure Test: | Episodic Memory Lowest score: 0 Highest Score: 8 | up to 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Stropp Test | Executive Function | up to 12 month |
| Trail Making Test | Executive Function | up to 12 month |
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Inclusion Criteria:
• elective open heart surgery requiring cardiopulmonary bypass
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Schricker, M.D., PhD. | Contact | 5149341934 | thomas.schricker@mcgill.ca | |
| Hiroaki Sato, M.D., PhD. | Contact | 5149341934 | 64275 | hiroaki.sato2@mcgill.ca |
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|
| Normal Saline Flush, 0.9% Injectable Solution | Drug | Placebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery |
|
| Tower of London test | Executive Function | up to 12 month |
| Symbol Digit Modalities Test | Information Processing Speed | up to 12 month |
| Boston Naming Test | Language Lowest score: 0 Highest score: 60 | up to 12 month |
| Clock Drawing Test | Visuospatial Function Lowest score: 1 Highest score: 10 | up to 12 month |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D006331 | Heart Diseases |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002318 | Cardiovascular Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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