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IRCT20231123060154N1 IRCT 2023-12-03 Qazvin University of Medical Sciences Comparison of the effect of oral sotalol and oral metoprolol succinate in the prevention of atrial fibrillation after coronary artery bypass surgery. Evaluation of the effect of oral sotalol in comparison with oral metoprolol succinate in prevention of atrial fibrillation in patients after coronary artery bypass graft surgery 2023-12-22 anticipated 188 Complete https://irct.ir/trial/74066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: To implement random allocation, creating a random sequence using the "Random Allocation Law" method will be used. Thus, after determining the sample size, among the people identified in the first stage, several people who meet the criteria for entering the study, are willing to participate in the study and sign the informed consent form, will be selected using the accessible method. In the second stage, each of these selected people will be assigned a numerical order from 1 to 188. In the third step, 188 random sequences created by Statistics and Sample Size software (random numbers without repetition between 1 and 188) will be considered to include people in the study. Each of these numbers will correspond to the number assigned to a person, which is specified in the first list of 188. The numbers will be assigned to the intervention group (prescribing sotalol) and the control group in sequence, and this sequence will be repeated to obtain the desired number of samples for each group. How the random assignment will be performed and to which group the individual will be specialized will not be obvious to the participants, Blinding description: Doctors and researchers collecting data and investigating the outcome and health care personnel will be unaware of the intervention groups. Sotalol and metoprolol succinate drugs have been prepared and will be placed in the hospital without its medicinal properties. Medication packages are prepared by a separate pharmacist. A special code for the type of drug is specified on each package, which identifies it in the study database. 3 Condition 1: coronary artery bypass graft. Condition 2: Atrial fibrillation and flutter. Intervention 1: Intervention group: Sotalol tablets are prescribed 24 hours before surgery and up to 3 days after surgery. Sotalol is started with a dose of 40 mg per day and is increased or decreased based on the patient's heart rate. The patient's heart rate is maintained at 55-60. Intervention 2: Intervention group: Metoprolol succinate tablets 24 hours before the operation and up to 3 days after the operation with a daily dose of 47.5 mg is decreased or increased based on the patient's heart rate. The prescribed dose is adjusted based on the patient's clinical response and the patient's heart rate is maintained at 55-60. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Academic and scientific researchers and Industries Conditions: Permission is granted to use the data for meta-analysis or to design other studies Where to obtain: ارائه درخواست از طریق ایمیل NADERIHD@GMAIL.COM How to obtain: If the applicant submits a request, if 6 months have passed since the publication of the article, it will be answered in less than 1 week. Comments:
public hadi naderi
Bouali Hospital, Bouali Street
qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 naderihd@gmail.com Qazvin University of Medical Sciences scientific hadi naderi
Bouali Hospital, Bouali Street
qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 naderihd@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for CABG 18 years 80 years Both Previous history of atrial fibrillation Having a permanent pacemaker Any definite or probable evidence of having any type of ventricular or supraventricular arrhythmia Moderate and severe LV enlargement Moderate and severe valvular heart disease acute MI Prolonged QT Patients with severe renal impairment and ESRD Asthma and bronchospasm Patients with hemodynamic disorders and low blood pressure Patients who are taking drugs that interact with sotalol will be excluded from the study if it is not possible to stop the drug. These drugs include: All QT prolonging drugs including: Amiodarone, Amisulpride, Azithromycin, Carbetocin, Ceritinib, Chloroquine, Citalopram, Clarithromycin, Clofazimine, Clomipramine, Clozapine, Dabrafenib, Dasatinib, Domperidone, Doxepine-containing products, Droperidol, Encorafenib, Entrectinib ) Nilotinib, Olanzapine, Ondansetron, Osimertinib, Oxytocin, Pacritinib, Pazopanib, Pentamidine, Pilsicainide, Pimozide, Piperaquine, Probucul, Propafenone, Propofol, Quetiapine, Ribociclib, risperidone, Sertindole, Sparfloxacin, Sunitinib, Terbutaline, Thioridazine, Toremifene, Vemurafenib : Alfuzocin, Alpha1- Blockers, Amifostine, Phenothiazines, Barbiturates, Benperidol, Levodpa- Containing products, Lormetazepam, Methoxyflurane, Molsidomine, Naftopidil, Nicergoline, Nicorandil, Nifedipine, Nitroprusside, Obinutuzumab, Pentoxyfilline, Pholcodine, Phosphodiesterase 5 inhibitors, Prostacyclin, Quinagolide, Reserpine: Acetylcholinesterase inhibitors, Ceritinib, Dipyridamole, Etilefrine, Ivabradine, Lacosamide, Midodrine, Ozanimod, Ponesimod, Siponimod, Blood sugar lowering drugs: Insulins, Sulfonylureas, Antidiabetic agents I25.7 I48 Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris Atrial fibrillation and flutter Treatment - Drugs Treatment - Drugs Intervention group: Sotalol tablets are prescribed 24 hours before surgery and up to 3 days after surgery. Sotalol is started with a dose of 40 mg per day and is increased or decreased based on the patient's heart rate. The patient's heart rate is maintained at 55-60. Intervention group: Metoprolol succinate tablets 24 hours before the operation and up to 3 days after the operation with a daily dose of 47.5 mg is decreased or increased based on the patient's heart rate. The prescribed dose is adjusted based on the patient's clinical response and the patient's heart rate is maintained at 55-60. Occurrence of atrial fibrillation. Timepoint: Patients are continuously cardiac monitored for atrial fibrillation. Method of measurement: ECG. Qazvin University of Medical Sciences Approved 2023-11-18 Ethics Committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Bahonar boulevard, Ethics committee of Qazvin University of Medical Sciences qazvin Qazvin Iran (Islamic Republic of)