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

McGill University logo

McGill University

Status

Unknown

Conditions

Delirium
Cognitive Decline
Heart Diseases

Treatments

Drug: Normal Saline Flush, 0.9% Injectable Solution
Drug: Regular insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT03324867
2018-3964

Details and patient eligibility

About

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.

Enrollment

316 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

316 participants in 2 patient groups, including a placebo group

Intranasal Insulin 40 IU
Experimental group
Description:
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to POD 7
Treatment:
Drug: Regular insulin
Intranasal Normal Saline
Placebo Comparator group
Description:
Normal Saline via nose Before surgery and everyday after surgery up to POD 7
Treatment:
Drug: Normal Saline Flush, 0.9% Injectable Solution

Trial contacts and locations

0

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Central trial contact

Hiroaki Sato, M.D., PhD.; Thomas Schricker, M.D., PhD.

Data sourced from clinicaltrials.gov

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