The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery

Conditions
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Cognitive Decline, Heart Diseases, Delirium

Intervention / Treatment
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* Drug: Regular insulin
* Drug: Normal Saline Flush, 0.9% Injectable Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Insulin 40 IU<br>40 IU of Humulin-R via nose Before surgery and everyday after surgery up to POD 7 | Drug: Regular insulin<br>* 40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.<br>* Other names: Humulin R;|
| Placebo Comparator: Intranasal Normal Saline<br>Normal Saline via nose Before surgery and everyday after surgery up to POD 7 | Drug: Normal Saline Flush, 0.9% Injectable Solution<br>* Placebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stropp Test | Executive Function | up to 12 month | 
| Trail Making Test | Executive Function | up to 12 month | 
| 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 |