Efficacy of Melatonin in Reducing the Incidence of Delirium in Elderly Postoperative Intensive care patients: A Double blind Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605474198292

Enrollment

180

Registered

2026-05-25

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Anaesthesia

Interventions

Standard care

melatonin low dose

melatonin High dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients aged >60 years of both sexes. Postoperative patients admitted to the ICU within 24 hours of surgery, before 8:00 PM. Patients who are not mechanically ventilated. Patients who can tolerate enteral feeding.

Exclusion criteria

Exclusion criteria: Pre-existing cognitive impairment or diagnosed dementia. History of psychiatric illness requiring ongoing treatment. Severe hepatic or renal impairment (e.g., Child-Pugh C liver disease, CKD stage 5). Known allergy or contraindication to melatonin. Patients receiving sedative-hypnotics or antipsychotics prior to ICU admission. Expected ICU stay <48 hours.

Design outcomes

Primary

Measure	Time frame
Incidence of delirium during the first 5 days of ICU stay, assessed twice daily (10:00 AM and 10:00 PM) using the CAM-ICU.	—

Secondary

Measure	Time frame
Need for and total dose of haloperidol.;Length of ICU stay (days).;ICU mortality.	—

Countries

Egypt

Contacts

Public ContactAbdalla Soliman

ICU Resident

Solimanabdallah265@gmail.com01063307702

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026