Post Operative Delirium Study

Delirium Clinical Trial

— PODS  

Official title:

Intranasal Insulin and Neurocognitive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635774
• Other study ID #: STUDY00146489
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 25, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: Angie Ballew, DC, MS
• Phone: 9139457420
• Email: aballew[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Those patients 65 and older undergoing surgery using vapor anesthesia, who are consented but do not exhibit delirium and are not part of the study are still considered recruited subjects, but are not in the active study.

Exclusion Criteria:

• 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

• thiazolidinediones

• hormones which may affect plasma glucose or insulin

• contraceptive, diphenylhydantoin

• patients with allergy to insulin

• acromegaly

• Cushing's syndrome

• hyperthyroidism and pheochromocytoma

• renal impairment

• pregnant and lactating women

• base line blood glucose < 3.9 mmol/L

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Insulin
40 IU via four activations of an intranasal spray
• Saline
Four activations of an intranasal spray containing placebo (normal saline).

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of intranasal insulin in resolving post-operative delirium	Measured by administering the Confusion Assessment Method (CAM) tool	10 min post diagnosis
Primary	Efficacy of intranasal insulin in resolving post-operative delirium	Measured by administering the Confusion Assessment Method tool	30 min post diagnosis
Primary	Efficacy of intranasal insulin in resolving post-operative delirium	Measured by administering the Confusion Assessment Method tool	60 min post diagnosis
Primary	Efficacy of intranasal insulin in resolving post-operative delirium	Measured by administering the Confusion Assessment Method tool	6 hours post diagnosis
Secondary	Length of stay in the post-anesthesia care unit (PACU)		Time from admission to the PACU until discharge from PACU, up to 18 hours from admission to the PACU