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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin 5mg | Experimental | Melatonin 5mg, every 24 hours for 14 days |
|
| Placebo | Placebo Comparator | Starch based placebo, every 24 hours for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 5 mg | Drug | Placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Diagnosis based Confusional Assessment Method Scale | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatima A Sánchez, Doctor of medicinen | Contact | 4441777616 | alon118@hotmail.com | |
| Antonio Gordillo, PhD | Contact | 4448262346 | 6688 | gordillo@uaslp.mx |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Gordillo, PhD | Universidad Autonoma de San Luis Potosí | Study Director |
| Fatima A Sánchez, Doctor of medicine | Universidad Autonoma de San Luis Potosí | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano Del Seguro Social | Recruiting | San Luis Potosí City | Mexico |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Parallel Assignament
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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |