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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
494
40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
Royal Victoria Hospital McGill University Health Centre
Montreal, Quebec, Canada
Confusion Assessment method for the ICU
Postoperative Delirium is assessment
Time frame: Up to 7 days after surgery
Rey Auditory Verbal Leaning
Episodic Memory Lowest score: 0 Highest Score: 15
Time frame: up to 12 month
Rey-Osterrieth Complex Figure Test
Episodic Memory Lowest score: 0 Highest Score: 8
Time frame: up to 12 month
Stroop Test
Executive Function
Time frame: up to 12 month
Trail Making Test
Executive Function
Time frame: up to 12 month
Tower of London test
Executive Function
Time frame: up to 12 month
Symbol Digit Modalities Test
Information Processing Speed
Time frame: up to 12 month
Boston Naming Test
Language Lowest score: 0 Highest score: 60
Time frame: up to 12 month
Clock Drawing Test
Visuospatial Function Lowest score: 1 Highest score: 10
Time frame: up to 12 month
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