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Effect of Intranasal Insulin on POCD and POD

NCT03415061 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2021-10-21

No results posted yet for this study

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.

Conditions

  • Delirium
  • Heart Diseases

Interventions

DRUG

Regular 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.

DRUG

Normal Saline Flush, 0.9% Injectable Solution

Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery

Sponsors & Collaborators

  • Hiroaki Sato, MD., PhD.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-11-30
Completion
2024-11-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415061 on ClinicalTrials.gov