Post Operative Delirium Study (PODS)

Intranasal Insulin and Neurocognitive Function

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Drug: Insulin; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Angie Ballew, DC, MS; Phone Number: 9139457420; Email: aballew@kumc.edu
• Study Contact Backup: Name: Manuel Clark, MPA; Phone Number: 913-945-5763; Email: mclark16@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Frank Weinhold, PharmD; Phone Number: 913-588-9900; Email: weinhold@ku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; The treatment group will receive 40 IU via four activations of an intranasal spray.	Drug: Insulin; 40 IU via four activations of an intranasal spray
Placebo Comparator: Placebo Group; The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).	Drug: Saline; Four activations of an intranasal spray containing placebo (normal saline).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Frank Weinhold, Pharm.D., MS, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Insulin
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: STUDY00146489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes