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

What Was Tested

The trial (not phased) is built around Insulin (regular human).

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).

It had two arms (groups): one (experimental) and Intranasal Normal Saline (placebo comparator).

Normal Saline via nose Before surgery and everyday after surgery up to POD 7.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 316 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: inability to provide informed consent; allergy to insulin; mother tongue other than english or french.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2022-04 with completion listed for 2023-04.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Confusion Assessment method for the ICU (time frame: an average of 5 days). Rey Auditory Verbal Leaning (time frame: up to 12 month). Rey-Osterrieth Complex Figure Test: (time frame: up to 12 month).

It also tracked 6 secondary outcomes, for example Stropp Test, Trail Making Test, Tower of London test, Symbol Digit Modalities Test, Boston Naming Test and Clock Drawing Test.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 316 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.