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Effects of Melatonin on incidence of delirium in the critically ill patients in ICU Maharaj Nakorn Chiang Mai hospital, A randomized control trial

Effects of Melatonin on incidence of delirium in the critically ill patients in ICU Maharaj Nakorn Chiang Mai hospital, A randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180504002
Enrollment
Unknown
Registered
2018-05-04
Start date
2016-12-01
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

Patient admitted in ICU Maharaj Nakorn Chiang Mai hospital

Interventions

The melatonin group will receive 2 mg of melatonin oral at 9.00 pm every day during ICU stay&#44
as well as the placebo group will receive placebo oral at the same time and same method. ,The placebo group will receive 1 tablet of placebo which has same characteristic&#44
made by pharmacist from faculty of Pharmacology&#44
Chiang Mai University.
Melatonin group,Placebo group

Sponsors

Faculty of medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: - age over 18 years old - admit in ICU with acute respiratory failure require mechanical ventilator - GCS > 10 - can receive enteral feeding

Exclusion criteria

Exclusion criteria: &#45; Have delirium at the time of enrolment &#45; prior treatment of sleep disturbance and delirium or use continuous intravenous sedative for deep sedative effects or muscle paralysis drugs &#45; pregnant and breast feeding &#45; history of neurological disease&#44; convulsion&#44; psychiatric &#45; conditions likely to affect the enteral absorption such as intestinal obstruction&#44; ileus&#44; gastroparesis &#45; expect length of stag < 48 hr &#45; known allergic to melatonin &#45; re&#45;admitted to ICU after randomized to study

Design outcomes

Primary

MeasureTime frame
The incidence of delirium occurs in patient admitted in ICU At the time of the ICU discharge Occurrence of delirium will be recorded every day during ICU stay using CAM&#45;ICU

Secondary

MeasureTime frame
Mechanical ventilator (MV) day Date of taking off MV Duration of MV dependent

Countries

Thailand

Contacts

Public ContactRujira Rujiwetpongston

Faculty of Medicine&#44; Chiang Mai University

ae.jaae.330@gmail.com089-5555502

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026