Comparison of dexmedetomidine injection alone or with the addition of oral melatonin on the incidence of delirium after coronary artery bypass graft surgery

Evaluation of the effect of dexmedetomidine supplementation with oral melatonin in the prevention of delirium after coronary artery bypass graft surgery

Randomized Clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients. Excel software rand function was used for randomization. Simple individual randomization by randomization table

Delirium is common after cardiac surgery. This study is performed in Golestan Hospital of Ahvaz as a double-blind randomized study

Inclusion criteria: Candidate for coronary artery bypass graft surgery with cardiopulmonary pump No allergy to melatonin and dexmedetomidine Elective surgery Exclusion criteria: Conscious dissatisfaction Emergency surgery Chronic use of melatonin or hypnotic drugs History of liver or kidney disease or chronic lung disease History of neurological or psychological diseases Ejection Fraction < 30%

1-Intervention group: In group 1, melatonin at a dose of 3 mg, the night before surgery (9 pm) and the morning of surgery (6 am) and every night (9 pm) for 48 hours after surgery. In the intensive care unit, dexmedetomidine will first receive a bolus of 0.5μg / kg for 20 minutes and then an infusion of -0.7 μg / kg / h for a maximum of 24 hours. 2-Control group: In group 2, placebo tablet, the night before surgery (9 pm) and the morning of surgery (6 am) and every night (9 pm) for 48 hours after surgery. In the intensive care unit, dexmedetomidine will first receive a bolus of 0.5μg / kg for 20 minutes and then an infusion of -0.7 μg / kg / h for a maximum of 24 hours

Delirium incidence; Intensity of delirium

This study is performed on patients candidate for CABG eczema referred to the partner medical centers in the project. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease, and symptoms, and randomly, using the patient code numbers, one group is group A (dexmedetomidine) and one group is group B (dexmedetomidine+melatonin). For randomization, the permutation block method with six blocks is done using Random allocation software.

To blind the study, after the patient enters the study, the doctor prescribes A (dexmedetomidine) or B (dexmedetomidine+melatonin) based on the randomized form. The doctor's prescription is prescribed in the same packages. Clinical caregivers are unaware of the coding assigned to each patient. The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not know about the codings. The results of the two groups under the headings of groups A and B will be submitted to the statistical analyst.