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

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187807
• Other study ID #: UAutonomaSLP
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: May 2020

Study information

• Verified date: December 2019
• Source: Universidad Autonoma de San Luis Potosí
• Contact: Fatima A Sánchez, Doctor of medicinen
• Phone: 4441777616
• Email: alon118[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Emergencies

Intervention

Drug:
• Melatonin 5 mg
Placebo

Locations

Country	Name	City	State
Mexico	Instituto Mexicano Del Seguro Social	San Luis Potosí

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	Diagnosis based Confusional Assessment Method Scale	14 days