Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
Overview
- Phase
- Not Applicable
- Intervention
- Regular Insulin, Human 100 UNT/ML
- Conditions
- Delirium
- Sponsor
- Hiroaki Sato, MD., PhD.
- Enrollment
- 494
- Locations
- 1
- Primary Endpoint
- Confusion Assessment method for the ICU
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Hiroaki Sato, MD., PhD.
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria
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.
Arms & Interventions
Intranasal Insulin 40 IU
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
Intervention: Regular Insulin, Human 100 UNT/ML
Intranasal Normal Saline
Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7
Intervention: Normal Saline Flush, 0.9% Injectable Solution
Outcomes
Primary Outcomes
Confusion Assessment method for the ICU
Time Frame: Up to 7 days after surgery
Postoperative Delirium is assessment
Rey Auditory Verbal Leaning
Time Frame: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 15
Rey-Osterrieth Complex Figure Test
Time Frame: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 8
Secondary Outcomes
- 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)