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IRCT20120215009014N392 IRCT 2021-05-02 Hamedan University of Medical Sciences Comparison of prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation Comparison of prophylactic effect versus therapeutic effect of amiodarone in patients undergoing heart surgery at risk of atrial fibrillation: a double-blind randomized clinical trial 2021-06-22 anticipated 200 Complete https://irct.ir/trial/55801 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Atrial fibrillation. Intervention 1: Intervention group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours before surgery. Intervention 2: Control group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours 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 It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Mehran Jabari Mehrabani
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 mehran_jabbari@yahoo.com Hamedan University of Medical Sciences scientific Dr. Ahmad Reza Salim Bahrami
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 salimbahramidr@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age: 18 to 65 years old Candidate for elective cardiac surgery Having a preoperative sinus rhythm 18 years 75 years Both Use of antihypertensive drugs other than beta-blockers or ACE inhibitors Thyroid, renal, pulmonary, hepatic disorders Asthma Bradycardia Heart failure Atrioventricular block Sensitivity to amiodarone I48.91 Unspecified atrial fibrillation Treatment - Drugs Treatment - Drugs Intervention group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours before surgery Control group: Intravenous infusion of amiodarone (manufactured by Shahr Daroo Pharmaceutical Co.) 350 mg 24 hours after surgery Incidence of atrial fibrillation. Timepoint: 24 hours after surgery. Method of measurement: Using a monitor machine. Incidence of side effects (such as hypotension and bradycardia). Timepoint: 24 hours after surgery. Method of measurement: using a monitor machine. Hamedan University of Medical Sciences Approved 2021-04-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)