Assessing the role of oral melatonin agonist ramelteon in prevention of ICU delirium

Evaluation of effect of oral melatonin agonist ramelteon for prevention of delirium in adult patients admitted in intensive care unit - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056002

Enrollment

Registered

2023-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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: Ramelteon: Melatonin Agonist Ramelteon 8mg will be given orally at night time for a total of 5 days. Control Intervention1: Lactose powder: Lactose powder as placebo will be given at ni

Eligibility

Inclusion criteria

Inclusion criteria: 1.With Preserved ORAL/Enteral intake by the Patient 2.With Richmond Agitation scale(RASS0 score within +2 or -2 during ICU stay

Exclusion criteria

Exclusion criteria: 1.Hemodynamically Unstable or Inotropic Support Patients 2.Patient on Psychotropic Drugs or Known psychiatric illness 3.Patient with debilitating Neurological diseases and Low GCS 4. Pregnant Patients

Design outcomes

Primary

Measure	Time frame
Incidence of deliriumTimepoint: Twice a day at 9 AM and 9 PM for a total period of 5 days	—

Secondary

Measure	Time frame
To Compare duration of ICU stay & mechanical ventilation in patients on Ramelteon versus who has not been administered RamelteonTimepoint: At the end of their Hospital Stay	—

Countries

India

Contacts

Public ContactDr Kashish Chawla

Vardhman Mahavir Medical College And Safdarjung Hospital

doctorrajpal04@gmail.com9911858311

Outcome results

None listed

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