The investigation of the effects of melatonin supplement on the rate of postoperative artrial fibrillation after coronary artery bypass grafting sutgery

Investigating the effect of melatonin supplementation on the prevention of atrial fibrillation in patients undergoing coronary artery bypass surgery

This study is a controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 154 patients. Random allocation chain to groups will be prepared using Random allocation software

Randomization based on random blocks; triple blinding strains are selected for Doctors, Researchers, Patients, etc., Patients who will undergo CABG surgery in the next 5 days at Shahid Rajaei Karaj hospital.Patients in the drug group receive Melatonin from 3 days before surgery and up to 5 days after. Control group patients also receive placebo in the same way. Patients are examined in a period of 8 days In the form of clinical examinations and questionnaires.

Inclusion criteria: patients 18 years or older who are candidates for coronary artery transplantation Exclusion critria: People with a history of atrial fibrillation;history of allergic reaction to melatonin;inability to swallow;with unstable hemodynamics; concurrent valve surgery; emergency surgery; history of any supraventricular arrhythmia; use of antiarrhythmic drugs; kidney failure; chronic liver disease; pregnancy and breastfeeding

A control group receiving standard of care plus placebo and a study group receiving standard of care plus oral melatonin 10 mg nightly from 3 days before surgery to 5 days after surgery

Primary outcome: rate of postoperative atrial fibrillation in the first 5 days after coronary artery bypass surgery Secondary outcome: examination of CK-MB level and increased troponin and hs-CRP; duration of POAF; The duration of hospitalization of patients in the intensive care unit and hospital

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.

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.