Post Operative Delirium Study

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human).

Post-operative delirium happens when patients wake up from anesthesia.

Patients experiencing post-operative delirium are very confused, not being able to think or function "normally".

These patients are hard to take care of and they tend to have more dementia as they age compared to patients who don't experience post-operative delirium.

It had two arms (groups): Treatment Group (active comparator) and Placebo Group (placebo comparator).

The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: All patients (\>65 years of age) undergoing elective surgery using vapor anesthesia displaying post-operative delirium as defined by a CAM evaluation within time to PACU discharge post-surgery are eligible.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: patients with a history of severe dementia, anoxic brain injury, or neuromuscular disorders; non-english-speaking patients; planned use of drugs that effect plasma glucose concentration during the first four hours of surgery.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 investigator.

It started in 2021-02-25 with completion listed for 2023-11-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Length of stay in the post-anesthesia care unit (PACU).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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