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Efficacy of Melatonin in Prevention of Delirium in Intensive Care Unit

Efficacy of Melatonin in Prevention of Delirium in Intensive Care Unit: A Prospective Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100537
Enrollment
96
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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: Nil: Nil Intervention2: Syrup Melatonin 3mg: Prophylactic melatonin syrup for prevention of delirium in critical care for 14 days

Sponsors

MEDICAL COLLEGE AND HOSPITALKOLKATA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults ( more than 18 years). Expected ICU stay more than 48 hours. Informed consent obtained from patient or legal guardian.

Exclusion criteria

Exclusion criteria: ICU admission more than 48 hours at the time of screening. Unable to assess for delirium (eg, coma or deep sedation; receiving neuromuscular blocking drugs) at the time of screening. History of severe cognitive or neurodegenerative disease (eg, dementia, Parkinson s disease) or severe structural brain injury (eg, traumatic brain injury, intracranial haemorrhage. Severe hepatic or renal dysfunction. Known allergy to melatonin. Absolute contradiction to enteral nutrition (eg, gastrointestinal obstruction,perforation,recent gastrointestinal surgery,deemed strict nil by mouth,lack of enteral access). Pregnant and lactating women. Active seizures.

Design outcomes

Primary

MeasureTime frame
Incidence of deliriumTimepoint: 14 Days

Secondary

MeasureTime frame
Duration of Delirium, Time to Onset of Delirium, Length of ICU Stay, Sedation Requirements, Sleep Quality, ICU mortalityTimepoint: 14 Days

Countries

India

Contacts

Public ContactAdhishree K

MEDICAL COLLEGE AND HOSPITAL,KOLKATA

adhikritigai2906@gmail.com9087325671

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026