NCT04635774

Post Operative Delirium Study

Intranasal Insulin and Neurocognitive Function

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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. Intranasal insulin has been shown to reverse confusion associated with Alzheimer's disease (humans) and AIDS (mice). Intranasal insulin has been safely administered to 1092 patients in 38 different studies. There were no cases of clinically low blood sugar and a few cases of mild nasal irritation that happened also with salt water when the subjects received multiple intranasal doses. No one has tried to reverse post-operative delirium with intranasal insulin. The delirium associated with Alzheimer's Disease and AIDS have very similar symptoms and what happens in the brain is very similar also. The investigators intent is to administer intranasal insulin to patients exhibiting post-operative delirium in order to reverse the symptoms because the investigators think that the three disease states are closely related and intranasal insulin has had some success in reversing the delirium in the other two disease states.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	Insulin	40 IU via four activations of an intranasal spray
DRUG	Saline	Four activations of an intranasal spray containing placebo (normal saline).

Timeline

• Start date: 2021-02-25
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2020-11-19
• Last updated: 2024-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study