The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial
Sultan Qaboos University
240 participants
Sep 30, 2024
INTERVENTIONAL
Conditions
Summary
The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.
Eligibility
Inclusion Criteria1
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
Exclusion Criteria14
- Patients admitted to the ward, however meeting requirement for vasopressors or non-invasive ventilation.
- Patient admitted through emergency to Intensive Care Unit (ICU) or High Dependency Unit (HDU).
- Aphasic patients.
- Patients with language barriers.
- Already taking melatonin or ramelteon at the time of randomization.
- Presence of delirium at the time of randomization.
- If enteral medications are contraindicated due to gastrointestinal conditions.
- If enteral medications are not allowed due to unavailability of nasogastric tube
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (liver function tests) > 3 times the upper limit of normal.
- Patient on strong cytochrome P450 1A2 (CYP1A2) inhibitors (namely: fluvoxamine and viloxazine) .
- Patient with active alcohol drinking or admitted with alcohol withdrawal syndrome.
- Subject or proxy unable to provide informed consent within 24 hours of admission.
- Patients with the following autoimmune diseases (Rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus).
- Allergy to melatonin.
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Interventions
Melatonin 5mg/day
Melatonin 8 mg/day
Placebo
Locations(2)
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NCT06509191