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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | The treatment group will receive 40 IU via four activations of an intranasal spray. |
|
| Placebo Group | Placebo Comparator | The placebo group will receive four activations of an intranasal spray containing placebo (normal saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | 40 IU via four activations of an intranasal spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of intranasal insulin in resolving post-operative delirium | Measured by administering the Confusion Assessment Method (CAM) tool | 10 min post diagnosis |
| Efficacy of intranasal insulin in resolving post-operative delirium | Measured by administering the Confusion Assessment Method tool | 30 min post diagnosis |
| Efficacy of intranasal insulin in resolving post-operative delirium | Measured by administering the Confusion Assessment Method tool | 60 min post diagnosis |
| Efficacy of intranasal insulin in resolving post-operative delirium | Measured by administering the Confusion Assessment Method tool | 6 hours post diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Weinhold, Pharm.D., MS | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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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.
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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.
| Saline |
| Drug |
Four activations of an intranasal spray containing placebo (normal saline). |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |