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Comparison of Low-Dose and High-Dose Melatonin for Prevention of Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery: A Randomized Controlled Trial

Comparison of Low-Dose and High-Dose Melatonin for Prevention of Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250424001
Enrollment
132
Registered
2025-04-24
Start date
2025-06-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative delirium in elderly patients undergoing orthopedic surgery Postoperative delirium, elderly, orthopedic

Interventions

Participants in this group will receive 2 mg of melatonin administered orally as a tablet once daily at bedtime for 5 consecutive nights. The first dose will be given the night before surgery (D-1) an
Experimental Drug,Experimental Drug
Low-dose Melatonin (2 mg),High-Dose Melatonin (6 mg)

Sponsors

Pranangklao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > 65 years 2. Undergoing non-emergency orthopedic surgery 3. ASA physical status I-III 4. Expected hospital stay > 72 hours postoperatively 5. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Pre-existing cognitive impairment (e.g. diagnosed dementia, Alzheimer disease) 2. Chronic melatonin use or history of sleep disorders 3. Severe hepatic impairment 4. Severe renal impairment 5. History of allergy to melatonin

Design outcomes

Primary

MeasureTime frame
Postoperative delirium 5 days postoperative Confusion Assessment Method (CAM)

Secondary

MeasureTime frame
Sleep quality 5 days postoperative Richards-Campbell sleep questionnaire,Length of hospital stay Hospital discharge Day,Melatonin side effects 5 days postoperative Assessor daily visit

Countries

Thailand

Contacts

Public ContactPornchanan Duriyaprapan

Pranangklao Hospital

pornchanand@gmail.com0824521042

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026