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To compare the effect of two doses of tablet melatonin on occurrence of ICU delirium

Comparison of the effect of two prophylactic doses of tablet melatonin on incidence of delirium in patients admitted in intensive care unit - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067172
Enrollment
120
Registered
2024-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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: Melatonin 6mg will be given orally at night time for a total of 5 days Control Intervention1: Melatonin: Melatonin 3mg will be given orally at night time for a total of 5 day

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preserved oral/enteral intake within the first 48 hours of ICU admission. 2. Patients requiring an ICU stay of at least 5 days. 3. Richmond Agitation Sedation Scale (RASS) score within + 2 or - 2 on admission

Exclusion criteria

Exclusion criteria: 1. Hemodynamically unstable patients or on vasopressor support 2. Patients on psychotropic medications or having known psychiatric illness 3. Patients with debilitating neurological diseases and low GCS less than 10 on admission 4. Pregnant patients 5. Patient with known or suspected allergy to melatonin

Design outcomes

Primary

MeasureTime frame
Incidence of deliriumTimepoint: Twice a day once at 9 am and after giving the melatonin tablet at 9pm for a period of 5 days

Secondary

MeasureTime frame
1. To compare length of Intensive Care Unit stay in 2 study groups. 2. To compare the incidence of headache, dizziness and day-time sleepiness between the two study groups.Timepoint: At the end of their hospital stay

Countries

India

Contacts

Public ContactDr Santvana Kohli

Vardhman Mahavir Medical College and Safdarjung Hospital

dr.santvana.kohli@gmail.com7838434398

Outcome results

None listed

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