Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke

JUSTIFICATION AND OBJECTIVES The objective of this study is to evaluate the protective effect of melatonin on the brain in patients with cerebral infarction. Cerebral infarction is the death of a small part of the brain that can leave moderate or severe disabilities, such as paralysis or death. The current treatment does not attempt to stop all the mechanisms of brain damage that occur with this disease. Melatonin is a substance that probably protects the brain by regulating cell responses to decrease damage and death of brain cells, in addition to decreasing and cushioning the secretion of substances that produce greater damage at the site of the lesion. These effects have been tested in other heart and neurological diseases in children and adults. However, its effectiveness in this disease in humans has not been studied, so it will be evaluated in this study. This medication is already approved for use in humans to improve sleep quality, so its use is safe, and the side effects are mild and may consist of headache, feeling sleepy during the day, and dizziness. These effects are discussed in detail in the risks and discomfort section.

PROCEDURES You will receive the usual treatment and studies for the care of cerebral infarction. In addition, you will be administered melatonin or lactose orally, forming two groups to evaluate the medication's effectiveness. The group will be assigned in a sequentially numbered envelope that I will give you containing your medication, which was previously sorted by someone outside the research, so neither the researcher, nor the doctor, nor you will know which group you are in. It is essential to mention that lactose tablets will have no effect.

The treatment consists of one tablet every 12 hours for 7 days and then one tablet every 24 hours at night until completing 83 days. We will perform a head CT scan upon admission, on day 2, and on day 90. We will also take blood samples for the laboratory (approximately two teaspoons of blood) on days 0 (upon admission), 5, 30, and 90 to measure substances in the blood that may be modified by the medication and confirm its protective effect on the brain. During your hospital stay, your treating physician will evaluate you daily, and we will perform evaluations on days 3 and 5. Once discharged, the patient will attend monthly medical follow-up appointments on days 30, 60, and 90 after the infarction.

The blood samples will be stored for later evaluation, within a period of fewer than 3 years, with the support of the Universidad Michoacana de San Nicolás de Hidalgo and the Centro de Investigación Biomédica de Michoacán. These samples may be used for future research if you authorize them.

If you decide to participate, you will take your medication according to the instructions. We will monitor you during your hospitalization, and you will attend monthly appointments on days 30, 60, and 90. During these appointments, we will perform clinical evaluations, administer questionnaires, conduct a CT scan, take blood samples, and provide melatonin or a placebo. Each appointment will require 60 minutes to perform all the interventions mentioned.