Delirium, Heart Diseases
Conditions
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.
Interventions
DRUGRegular Insulin, Human 100 UNT/ML
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
Sponsors
Hiroaki Sato, MD., PhD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confusion Assessment method for the ICU | Up to 7 days after surgery | Postoperative Delirium is assessment |
| Rey Auditory Verbal Leaning | up to 12 month | Episodic Memory Lowest score: 0 Highest Score: 15 |
| Rey-Osterrieth Complex Figure Test | up to 12 month | Episodic Memory Lowest score: 0 Highest Score: 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symbol Digit Modalities Test | up to 12 month | Information Processing Speed |
| Stroop Test | up to 12 month | Executive Function |
| Clock Drawing Test | up to 12 month | Visuospatial Function Lowest score: 1 Highest score: 10 |
| Boston Naming Test | up to 12 month | Language Lowest score: 0 Highest score: 60 |
| Trail Making Test | up to 12 month | Executive Function |
| Tower of London test | up to 12 month | Executive Function |
Countries
Canada
Contacts
Primary ContactThomas Schricker, M.D., PhD.
Backup ContactHiroaki Sato, M.D., PhD.
Outcome results
None listed