Effect of Intranasal Insulin on POCD and POD

Hiroaki Sato, MD., PhD.

Status: Not yet enrolling

Conditions: Delirium; Heart Diseases

Treatments: Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: Regular Insulin, Human 100 UNT/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03415061

20184334

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: 494 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

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494 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 postoperative day 7

Treatment:

Drug: Regular Insulin, Human 100 UNT/ML

Intranasal Normal Saline

Placebo Comparator group

Description:

Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7

Treatment:

Drug: Normal Saline Flush, 0.9% Injectable Solution