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IRCT20180909040979N7 IRCT 2022-05-24 Ahvaz University of Medical Sciences The effect of dexmedetomedine and melatonin on delirium Comparison of dexmedetomidine injection alone or with the addition of oral melatonin on the incidence of delirium after coronary artery bypass graft surgery 2022-05-22 anticipated 80 Complete https://irct.ir/trial/61732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Patients candidate for coronary artery bypass graft surgery. Intervention 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. Intervention 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Javaherforoosh zadeh
No.1, West Maroon, East13, Kianpars
Ahvaz Iran (Islamic Republic of) 6155979939 +98 61 3391 9315 f_javaherforoosh@yahoo.com Ahvaz University of Medical Sciences scientific Fatemeh Javaherforoosh zadeh
No.1, West Maroon, East13, Kianpars
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3391 9315 f_javaherforoosh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Candidate for coronary artery bypass graft surgery with cardiopulmonary pump No allergy to melatonin and dexmedetomidine Elective surgery Age 40 to 75 years 40 years 75 years Both 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% T82.9 Unspecified complication of cardiac and vascular prosthetic device, implant and graft Treatment - Drugs Placebo 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 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. Timepoint: First day and second day after extubation. Method of measurement: Based on Confusion Assessment Method for the ICU. Severity of delirium. Timepoint: First day and second day after extubation. Method of measurement: Based on Confusion Assessment Method for the ICU. Mechanical ventilation duration. Timepoint: 6,8,10,12 ,24 hours after surgery. Method of measurement: Hour. Duration of ICU staying. Timepoint: 2,3,4 days after surgery. Method of measurement: Day. Ahvaz University of Medical Sciences Approved 2022-04-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)