Effect of Intranasal Insulin on POCD and POD

Not Applicable

Not yet recruiting

• Conditions: Heart Diseases; Delirium
• Interventions: Drug: Regular Insulin, Human 100 UNT/ML; Drug: Normal Saline Flush, 0.9% Injectable Solution

• Registration Number: NCT03415061
• Lead Sponsor: Hiroaki Sato, MD., PhD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21
• Study Start: 2021-11-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 494

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Insulin 40 IU	Regular Insulin, Human 100 UNT/ML	40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
Intranasal Normal Saline	Normal Saline Flush, 0.9% Injectable Solution	Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stroop Test	up to 12 month	Executive Function
Trail Making Test	up to 12 month	Executive Function
Tower of London test	up to 12 month	Executive Function
Symbol Digit Modalities Test	up to 12 month	Information Processing Speed
Boston Naming Test	up to 12 month	Language Lowest score: 0 Highest score: 60
Clock Drawing Test	up to 12 month	Visuospatial Function Lowest score: 1 Highest score: 10

Trial Locations

Locations (1)

Royal Victoria Hospital McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada