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IRCT20230902059320N1 IRCT 2023-10-14 Karaj University of Medical Sciences The investigation of the effects of melatonin on the rate of postoperative artrial fibrillation after coronary artery bypass grafting sutgery The investigation of the effects of melatonin supplement on the rate of postoperative artrial fibrillation after coronary artery bypass grafting sutgery 2023-10-22 anticipated 154 Complete https://irct.ir/trial/72715 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization based on random blocks (Permuted Block Randomization) Unit of randomization: Individual patients Randomization tool: Sealed envelope containing intervention group By using random block tables, 39 blocks of 4 members according to a total of approximately 154 sample size will be chosen. Within each block there will be 2 Interventions and 2 placebos. Permutations will be random and allocation to the study groups will be applied by using sealed envelope. Patients and medical providers will be unaware of the randomization scheme and study groups, Blinding description: Healthcare Personnel (Includeincludeing Doctors, Nurses), Students (Principal Researcher), Participants, and the Person Evaluating the Results and the Analyst Do not Know About Receiving the Drug or Placebo. A Concealment envelope will assign patients to intervention group according to random block table. Melatonin and placebo capsule will be identical for keeping patients and medical providers blinded. 3 Atrial fibrillation. Intervention 1: Patients receiving melatonin 10 mg tablets at night, 1 tablet from 3 days before surgery to 5 days after surgery. Intervention 2: Control group: Patients receiving placebo, 1 tablet at night from 3 days before surgery to 5 days after surgery. 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 further information
public Pantea Parandeh
No. 1,Alley 31,South Parvaneh St., Ferdous Gharb Blvd.,Tehran Town
Tehran Iran (Islamic Republic of) 1483637886 +98 21 4415 5238 P.Parandeh.Pharmacist@gmail.com Karaj University of Medical Sciences scientific Pantea Parandeh
No. 1,Alley 31., South Parvaneh St.,Ferdous Gharb Blvd., Tehran Town
Tehran Iran (Islamic Republic of) 1483637886 +98 21 4415 5238 P.Parandeh.Pharmacist@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 years or older, whose blood supply disorder to the heart makes them candidates for coronary artery baypass grafting surgery Signing the consent form by the patient or the patient's qualified companion 18 years no limit Both People with a history of atrial fibrillation People with a history of allergic reactions to melatonin or other ingredients in the tablet People with the inability to swallow the oral form of melatonin in tablet form People with unstable hemodynamics before surgery People undergoing heart valve surgery at the same time Emergency coronary artery bypass surgery People with a previous history of any supraventricular arrhythmia Use of antiarrhythmic drugs People with kidney failure People with chronic liver disease Pregnant or lactating women I48.0 Paroxysmal atrial fibrillation Prevention Prevention Patients receiving melatonin 10 mg tablets at night, 1 tablet from 3 days before surgery to 5 days after surgery Control group: Patients receiving placebo, 1 tablet at night from 3 days before surgery to 5 days after surgery Percentage of people who suffer from atrial fibrillation after coronary artery bypass surgery. Timepoint: The incidence of atrial fibrillation after surgery in the first five days after CABG surgery. Method of measurement: Atrial fibrillation is diagnosed based on the absence of distinct repetitive P waves followed by irregular RR intervals lasting at least 30 seconds on a 12-lead ECG obtained from the patient. Examining the levels of CK-MB enzyme; troponin protein and hs-CRP. Timepoint: From one day before the operation to the first 5 days after the operation. Method of measurement: Checking the results of laboratory measurements and the information recorded in the patient's file. Duration of atrial fibrillation after surgery. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person has atrial fibrillation after coronary artery bypass surgery and recording information based on the patient's file. Duration of hospitalization in the intensive care unit. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file. Duration of hospitalization. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized and based on the patient's admission file. Karaj University of Medical Sciences Approved 2023-06-24 Ethics committee of Alborz University of Medical Sciences No.1, Alley 31.,South Parvaneh St.,Ferdous Gharb Blvd.,Tehran Town Alborz Alborz Iran (Islamic Republic of)