Post Operative Delirium Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2023-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The investigational pharmacist will use randomization software to randomize numbers 1-30. Each number will be randomized to either active drug (regular insulin) or placebo (normal saline).The investigational pharmacist will have the randomization table should un-blinding be required.

Study Groups

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Treatment Group

The treatment group will receive 40 IU via four activations of an intranasal spray.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

40 IU via four activations of an intranasal spray

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Four activations of an intranasal spray containing placebo (normal saline).

Interventions

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Insulin

40 IU via four activations of an intranasal spray

Intervention Type DRUG

Saline

Four activations of an intranasal spray containing placebo (normal saline).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No