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IRCT20151109024975N8 IRCT 2018-07-07 Mazandaran University of Medical Sciences Efficacy of Oral Amiodarone in atrial fibrillation after open heart surgery Efficacy of Oral Amiodarone Administration on Prevention of Cardiac Arrhythmia Following Open Heart Surgery, aRandomized Clinical trial Study 2016-04-20 anticipated 400 Complete https://irct.ir/trial/20971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random method and description of each method: simple randomization After determining the size of the sample, 400 people, 200 in the control group and 200 in the intervention group were considered. By co-ordinating medical records, this number was considered average for the duration of the appointment, and then the list of individuals was determined. The list was prepared based on the patients' turn-by-turn and then, using the random numbers table, the numbers of the control and intervention group were determined and compared to the coordination for the next steps, Blinding description: Patients and therapists are not aware of the type of drug present in the pills (amiodarone or vitamin B1), and only the researcher knows about the code inserted (code A or code B) on the pill pack. 3 Arrhythmia after open heart surgery. Intervention 1: Control group: Patients in the control group received placebo (vitamin B1). The frequency and duration of placebo in the control group were similar to the oral administration of amiodarone tablets in the intervention group (twice a day and up to discharge). Patients undergoing coronary artery bypass grafting, the drug is fed through the nasopharyngeal tube. The placebo is structurally similar to the amiodarone tablet, which is used in this study with a 300mg of vitamin B1 tablet that looks similar to the 200mg tablet in terms of its appearance. Intervention 2: Intervention group: 200 mg of amiodarone is given orally twice a day until the patient's discharge. . Patients who underwent coronary artery bypass grafting were injected through the nasopharyngeal tube. . Electrocardiogram monitoring was conducted continuously and monitored and educated nurses monitored the monitor frequently, and if any irregularities in rhythm were observed, they identified the type of arrhythmia of the patients and recorded the questionnaires. Eventually, the prevalence of cardiac arrhythmias and other items in the questionnaire was recorded in the questionnaires up to one week after the open heart surgery in the patients. 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 No more information
public Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences scientific Gohar Eslami
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3354 3695 g.eslami@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Candidate for open heart surgery Preoperative sinus rhythm Normal function of liver, renal system , pulmonary system and thyroid 18 years 80 years Both History of atrial and ventricular arrhythmia and cardiac blocks with any degree before surgery Patient's need for Pace Anti-arrhythmic therapy before surgery The history of thyroid and lung and renal disease and hepatitis Age over 80 years Pregnant patients Allergy to Amiodarone Placebo Treatment - Drugs Control group: Patients in the control group received placebo (vitamin B1). The frequency and duration of placebo in the control group were similar to the oral administration of amiodarone tablets in the intervention group (twice a day and up to discharge). Patients undergoing coronary artery bypass grafting, the drug is fed through the nasopharyngeal tube. The placebo is structurally similar to the amiodarone tablet, which is used in this study with a 300mg of vitamin B1 tablet that looks similar to the 200mg tablet in terms of its appearance. Intervention group: 200 mg of amiodarone is given orally twice a day until the patient's discharge. . Patients who underwent coronary artery bypass grafting were injected through the nasopharyngeal tube. . Electrocardiogram monitoring was conducted continuously and monitored and educated nurses monitored the monitor frequently, and if any irregularities in rhythm were observed, they identified the type of arrhythmia of the patients and recorded the questionnaires. Eventually, the prevalence of cardiac arrhythmias and other items in the questionnaire was recorded in the questionnaires up to one week after the open heart surgery in the patients. Prevention of various types of arrhythmias after open heart surgery. Timepoint: Duration of hospitalization. Method of measurement: monitoring. Duration of admission to ICU. Timepoint: Duration of hospitalization. Method of measurement: Monitoring and file. Duration of hospitalization. Timepoint: Duration of hospitalization. Method of measurement: Monitoring and file. Side effects of amiodarone. Timepoint: Duration of hospitalization. Method of measurement: Monitoring and file. Mazandaran University of Medical Sciences Approved 2017-04-09 Ethics Committee of Mazandaran University of Medical Sciences Research Deputy of Mazandaran University of Medical Sciencesm Moalem Square Sari Mazandaran Iran (Islamic Republic of)