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IRCT20180430039488N2 IRCT 2020-05-03 Tehran University of Medical Sciences Efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation Evaluation of the efficacy of intravenous administration of magnesium and pottasium solution in cardioversion of postoperative atrial fibrillation: a randomized, double blind, placebo-controlled trial 2019-11-22 anticipated 360 Complete https://irct.ir/trial/47491 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: permuted block randomization containing 4 subjects in each block eg : AABB. A refers to intervention group and B refers to controls, Blinding description: After randomization and assignment of patients to group A or B, the appropriate solution for each group is prepared and infused by the nurse according to the protocol, but the patient,the person collecting the data, the researcher and the evaluator of the outcome will be unaware of the patient's treatment group as well as the type of solution that the patient has received. Collected data of the study will be entered in the SPSS and then analysed by an independent expert from Tehran heart center research institute. 3 Postoperative atrial fibrillation. Intervention 1: Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and Potassium/Magnesium solution (10 cc of 15% potassium chloride solution of Shahid Ghazi company and 4 cc of 50% magnesium sulfate solution of Shahid Ghazi company diluted in 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed. Intervention 2: Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and placebo ( 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed. Yes - There is a plan to make this available What will be shared: Particular parts of the data will be released When: After release of the results To whom: Scientific institutions Conditions: Further analysis Where to obtain: Zohre Mohammadi ,MD How to obtain: Formal or official request by an institution Comments:
public Farzad Masoudkabir
Jala-AL ahmad high way, North Kargar street
Tehran Iran (Islamic Republic of) 3135674193 +98 21 8802 9600 Fmasoudkabir@sina.tums.ac.ir Tehran University of Medical Sciences scientific Zohre Mohammadi
Jala-AL ahmad highway, North Kargar street
Tehran Iran (Islamic Republic of) 3135674193 +98 21 8802 9600 zohrem28@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Atrial fibrillation after isolated coronary artery bypass graft surgery Continuation of atrial fibrillation rhythm for at least 15 minutes after initiation Serum Potassium level of 4-4.5 meq/L Serum Magnesium level of 4-4.5 meq/L Informed consent to participate in the study no limit no limit Both Unstable hemodynamic (systolic blood pressure less than 90 mmHg) History of atrial fibrillation (persistent or paroxysmal) before surgery Serum creatinine level more than 1.4 mg/dl More than 12 hours have passed since the beginning of the atrial fibrillation rhythm Patients receiving packed cell Hemoglobin level less than 7 g/L Spontaneous cardioversion before randomization Patients receiving Inotrope I97.89 Other postprocedural complications and disorders of the circulatory system, not elsewhere classified Treatment - Drugs Placebo Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and Potassium/Magnesium solution (10 cc of 15% potassium chloride solution of Shahid Ghazi company and 4 cc of 50% magnesium sulfate solution of Shahid Ghazi company diluted in 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed. Intervention group: administration of a Metoprolol succin tablet 47.5 mg (Metohexal) and placebo ( 250 cc of half saline serum, infused over 60 minutes). If the sinus rhythm does not restore after 6 hours, Amiodarone infusion (150 mg Amiodarone of Alborz Daru company within 10 minutes, then 1 mg per minute for 6 hours, and then 0.5 mg per minute for 18 hours) would be initiated. After Amiodarone infusion, the patient is treated with 200 mg Amiodarone tablets every 12 hours. If restoration of sinus rhythm occurs within the first 6 hours, Amiodarone will not be prescribed. Cardioversion of atrial fibrillation to sinus rhythm within the first 6 hour. Timepoint: From the start of the intervention until 6 hours later. Method of measurement: Cardiac rhythm monitoring. Time required to convert atrial fibrillation rhythm to sinus rhythm (in the first 6 hours). Timepoint: From the start of the intervention until 6 hours later. Method of measurement: Cardiac rhythm monitoring. Heart rate less than 110 beats per minute during the first 3 hours of treatment. Timepoint: From the start of the intervention until 3 hours later. Method of measurement: Cardiac rhythm monitoring. The rate of recurrence of atrial fibrillation in the first 48 hours after the restoration of sinus rhythm. Timepoint: From the time of sinus rhythm restoration to 48 hours later. Method of measurement: Cardiac rhythm monitoring. The rate of sinus rhythm restoration within 24 hours of Amiodarone initiation. Timepoint: From the initiation of Amiodarone infusion to 24 hours later. Method of measurement: Cardiac rhythm monitoring. The cumulative dose of Amiodarone required to restore sinus rhythm. Timepoint: From the initiation of Amiodarone infusion to restoration of sinus rhythm. Method of measurement: The total amount of Amiodarone that is prescribed until restoration of sinus rhythm. The time required to restore the sinus rhythm after initiation of Amiodarone infusion. Timepoint: From the initiation of Amiodarone infusion to restoration of sinus rhythm. Method of measurement: Total sum of time, in minutes, from the initiation of Amiodarone infusion to restoration of sinus rhythm. The rate of bradycardia (heart rate less than 60/minute) in the first 6 hours after starting intervention. Timepoint: From the start of the intervention until 6 hours later. Method of measurement: Cardiac rhythm monitoring. The rate of systolic blood pressure less than 90 mm Hg in the first 6 hours after starting intervention. Timepoint: From the start of the intervention until 6 hours later. Method of measurement: Blood pressure monitoring. Tehran University of Medical Sciences Approved 2019-07-21 Ethics committee of Tehran University of Medical Sciences Jala-Al-ahmad highway, North Kargar street Tehran Tehran Iran (Islamic Republic of)