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A Clinical Trial to study the effect of Intranasal Insulin in the prophylaxis of ICU Delirium

Efficacy of Intranasal Insulin in the prophylaxis of ICU Delirium: A Single center double blined prospective randomized trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087534
Enrollment
66
Registered
2025-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intranasal Insulin: Long acting Intranasal Insulin 20 IU to be administered twice daily in ICU patients for the period of 10 days or till discharge from ICU whichever is earlier Control

Sponsors

DrMeghna Kahlon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both male and female aged 18-70 years with expected ICU stay of more than 24 hours

Exclusion criteria

Exclusion criteria: Already delirious or pre-existing cognitive dysfunction Pregnant patients Patients with irreversible brain damage or acute brain injury Hepatic encephalopathy or liver cirrhosis with a Child Pugh Score B or C Comatose patients who cannot be assessed for delirium Patients in whom intranasal drug administration is contraindicated Patients with hypoglyceamia at the tme of presentation RASS -4 OR -5

Design outcomes

Primary

MeasureTime frame
Incidence of deliriumTimepoint: Within the first 10 ICU days

Secondary

MeasureTime frame
The number of positive CAM-ICU counts Duration of delirium Duration of mechanical ventilation Length of ICU stay Length of hospital stay Duration of intubation Successful extubation Need for antipsychotics/sedatives and dosages used ICU mortality Any adverse side effects due to intranasal insulinTimepoint: within the period of 10 days or discharge

Countries

India

Contacts

Public ContactVIKAS SAINI

PGIMER CHANDIGARH

drvsaini@gmail.com7087008119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026