Clinical trial NCT04635774: Post Operative Delirium Study
Official title: Intranasal Insulin and Neurocognitive Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Delirium
Keywords: Insulin
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is double-blind, randomized, placebo controlled. Neither the physician, patient, nor investigator will be aware of which patient is receiving insulin and which is receiving placebo. The treatment group will receive 40 IU via four activations of an intranasal spray. The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).

Both groups of patients receiving the insulin or placebo as intervention will be assessed with the CAM assessment at 10 min, 30min, and 60 min, and 6hr.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of intranasal insulin in resolving post-operative delirium
timeFrame: 10 min post diagnosis
measure: Efficacy of intranasal insulin in resolving post-operative delirium
timeFrame: 30 min post diagnosis
measure: Efficacy of intranasal insulin in resolving post-operative delirium
timeFrame: 60 min post diagnosis
measure: Efficacy of intranasal insulin in resolving post-operative delirium
timeFrame: 6 hours post diagnosis
Secondary outcomes:
measure: Length of stay in the post-anesthesia care unit (PACU)
timeFrame: Time from admission to the PACU until discharge from PACU, up to 18 hours from admission to the PACU
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Frank Weinhold, Pharm.D., MS
role: PRINCIPAL_INVESTIGATOR
References: