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Can Melatonin prevent delirium in ICU patients or not ?

Prophylactic Melatonin for Delirium in Intensive Care Unit- an open labelled randomized control study - PROMEDIC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037315
Enrollment
50
Registered
2021-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: F05- Delirium due to known physiological condition

Interventions

Intervention1: Melatonin: Tablet Melatonin 3 mg HS by oral route or via Nasogastric tube Control Intervention1: Standard treatment in practice: According to ICU protocol, controls receive all standard

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Absence of delirium at the time of admission Expected ICU length of stay >48 hours

Exclusion criteria

Exclusion criteria: Pregnancy Lactating mothers Severe Neurological impairment Severe hepatic impairment

Design outcomes

Primary

MeasureTime frame
Incidence of Delirium in ICUTimepoint: Assessed every 24 hours for a maximum period of 1 week—

Secondary

MeasureTime frame
ICU and/or Hospital length of StayTimepoint: 1 week;Need and duration of mechanical ventilationTimepoint: 1 week;Need for Anti psychoticsTimepoint: 1 week;Number of delirium free assessmentsTimepoint: 1 week;Overall mortalityTimepoint: 1 week—

Countries

India

Contacts

Public ContactRamkumar M

All India Institute of Medical Sciences, New Delhi

anjantrikha@gmail.com9810977901

Outcome results

None listed

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