Skip to content

Evaluation of the role of melatonin as a potential drug for prevention of delirium in patients who have been operated and are admitted in the intensive care unit.

Evaluation of role of exogenous melatonin in prevention of delirium in postoperative patients admitted in the intensive care unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031183
Enrollment
140
Registered
2021-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Interventions

Intervention1: ADMINISTRATION OF ORAL MELATONIN TABLET 5MG AT 8 PM EVERYDAY FROM ADMISSION TO DISCHARGE: ADMINISTRATION OF ORAL TABLET MELATONIN 5MG AT 8PM EVERYDAY FROM ADMISSION INTO ICU TO DISCHARG

Sponsors

Dr Kriti Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Postoperative patients who are going to be ventilated more than 48 hours in the trauma ventilatory unit. 2. Adults (20years - 60 years) able to receive medication enterally (oral or via nasogastric tube) during first 48 hours of admission

Exclusion criteria

Exclusion criteria: â?? Not giving consent â?? Sensitivity or history of allergic reaction to melatonin supplement, â?? Pregnant â?? Patients with paralytic ileus. â?? Patient having expected stay or life expectancy of less than 48 hours â?? Preexisting Premorbid pathologies particularly cognitive dysfunction, dementia, psychiatric disorders or sleep disorders â?? Patients with history of head injury , substance abuse or withdrawal. â?? Patients with Hearing impairments

Design outcomes

Primary

MeasureTime frame
On the day of discharge/transfer patient will be assessed using the CAM-ICU (Confusion Assessment Method) scale. ï?¼ The patients will be categorized as â??Deliriousâ?? or â??Not Deliriousâ?? on the basis of the results from the CAM-ICU scale and results will be analyzed. Timepoint: from admission into ICU to discharge from ICU

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Kriti Gupta

King George Medical University

vipintheazad@gmail.com6387908355

Outcome results

None listed

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