Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

Universidad Autonoma de San Luis Potosí

Status: Unknown

Conditions: Delirium in Old Age

Treatments: Drug: Melatonin 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04187807

UAutonomaSLP

Details and patient eligibility

About

This study evaluates the efficacy of melatonin 5mg in the prevention of Delirium in the older adults in emergency department. Half of the participants will receive melatonin 5mg and the other half will use a starch-based placebo.

Full description

Melatonia is useful for the treatment of sleep disorders due to the interruption of the circadian rhythm, secondary to alterations caused by the environment. The doses of 5 to 10mg oral or sublingual can improve the quality of the sleep-wake cycle and alertness in short-term use.

Mechanism of action of melatonin are:

1. Binding to membrane receptors: MT1 and MT2 coupled to G protein
2. • Union to nuclear receptors.
3. • Interaction with cytosolic proteins.
4. • Antioxidant of direct and indirect action.
5. • Interaction with mitochondria.

Melatonin circulates 80% bound to albumin and the rest in free form in plasma, 85-90% is metabolized by 6-hydroxymelatonin in the liver, which is then conjugated with sulfuric acid (70-80%) or glucuronic ( 5-3%), and is excreted in urine and feces.

Melatonin and its metabolites act as catalytic antioxidants to safeguard mitochondrial electron transfer reactions, therefore, increases the efficiency of energy metabolism. Melatonin synthesis decreases significantly as age progresses and changes in the circadian cycle have been associated with accelerated aging.

Enrollment: 145 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology.
• Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member).

Exclusion criteria

• Patients with a history of dementia or previous neurological diseases.
• Patients with a history of psychiatric disorder.
• Patients diagnosed with any type of liver disease.
• Warfarin treatment.
• Delirium data on admission to the emergency department.
• Patients under invasive mechanical ventilation and sedation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups, including a placebo group

Melatonin 5mg

Experimental group

Description:

Melatonin 5mg, every 24 hours for 14 days

Treatment:

Drug: Melatonin 5 mg

Placebo

Placebo Comparator group

Description:

Starch based placebo, every 24 hours for 14 days

Treatment:

Drug: Melatonin 5 mg