Post Operative Delirium Study

NCT04635774 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: STUDY00146489
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Insulin

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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

Drug: Insulin

Placebo Group

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Insulin DRUG

40 IU via four activations of an intranasal spray

Treatment Group

Saline DRUG

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

Placebo Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Delirium; Insulin Resistance

Interventions

Insulin; Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Frank Weinhold, Pharm.D., MS

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 19, 2020
• Study Start: February 25, 2021
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)