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IRCT20210424051058N1 IRCT 2021-05-27 Hamedan University of Medical Sciences The effect of Amiodarone in heart surgery patients prone to atrial fibrillation Comparison of prophylactic and therapeutic effect of amiodarone in heart surgery patients at risk of atrial fibrillation 2021-06-21 anticipated 200 Complete https://irct.ir/trial/55825 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be randomly assigned to the prevention and Intervention group. For this purpose, 50 cards are prepared and written on 25 letters C means prevention and on the other 25 letters I means the Intervention group and each of them is placed in an envelope with aluminum foil and their lids are glued inside. We put a box. When patients arrive, we randomly remove one of the envelopes and open the lid. According to the selected letter (C or I) inside it, we assign the patient to the prevention and Intervention group. With the selection of each patient, the card is set aside so that all the cards are selected. Then return all the cards to the box and repeat this process four times to reach the desired sample size. 3 atrial fibrillation. Intervention 1: Intervention group: In the intervention group, patients will receive 350 mg of amiodarone as an intravenous infusion 24 hours before surgery. Within 30 minutes to 24 hours after admission to the ICU, patients are cared for and in the event of cardiac arrhythmias such as premature ventricular fibrillation; Premature atrial fibrillation; Branch blocks; Asystole; VT; VF ..... is recorded and also cardiac arrhythmias and interventions performed according to the opinion of the surgeon or anesthesiologist. Intervention 2: Control group: In the control group, amiodarone is injected after surgery and three minutes before removal of the aortic clamp. EKG is taken in case of arrhythmic symptoms (such as palpitations, tachycardia, hypotension, shortness of breath, etc.) and if arrhythmia is observed, the patient will be monitored continuously with EKG. Yes - There is a plan to make this available What will be shared: Information about the variables studied in this research will be shared. When: After publishing the relevant article To whom: researchers Conditions: The information that the researchers are looking for should not be exactly the same as the findings of the published article in this study. Apart from the mentioned cases, other analyzes and extraction of information considered by the researchers from the data are unimpeded. The study data will also be provided to researchers without the identity information of the study participants Where to obtain: mehran_jabbari@yahoo.com How to obtain: The researcher must first email the following account and submit his request: mehran_jabbari@yahoo.com If the researcher's request is approved, the data will be emailed to him / her within a maximum of one month. Comments:
public Mehran Jabbari
Besat hospital, Shahid Motahary Blv, Hamadan
Hamadan Iran (Islamic Republic of) 65176-19657 +98 918 811 2759 mehran_jabbari@yahoo.com Hamedan University of Medical Sciences scientific Mehran Jabbari
Besat hospital, Shahid Motahary Blv, Hamadan
Hamadan Iran (Islamic Republic of) 65176-19657 +98 918 811 2759 mehran_jabbari@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Candidate patients for elective cardiac surgery ASA class 2 & 3 Consent to participate in the study Having a sinus rhythm before surgery No history of amiodarone allergy no limit no limit Both Recipients of antihypertensive drugs except beta blockers and ACE inhibitors Patients with thyroid, renal, pulmonary, hepatic disorders Asthmatics Rate of less than 50 Heart failure Atrioventricular block I48 Atrial fibrillation and flutter Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, patients will receive 350 mg of amiodarone as an intravenous infusion 24 hours before surgery. Within 30 minutes to 24 hours after admission to the ICU, patients are cared for and in the event of cardiac arrhythmias such as premature ventricular fibrillation; Premature atrial fibrillation; Branch blocks; Asystole; VT; VF ..... is recorded and also cardiac arrhythmias and interventions performed according to the opinion of the surgeon or anesthesiologist Control group: In the control group, amiodarone is injected after surgery and three minutes before removal of the aortic clamp. EKG is taken in case of arrhythmic symptoms (such as palpitations, tachycardia, hypotension, shortness of breath, etc.) and if arrhythmia is observed, the patient will be monitored continuously with EKG. Atrial fibrillation: It means uncoordinated atrial activity and consequent mechanical atrial insufficiency. Timepoint: The outcome of the intervention will be reviewed and compared before the intervention and one week after the intervention. Method of measurement: ECG. Hamedan University of Medical Sciences Approved 2021-04-09 Ethics Committee of Hamadan University of Medical Sciences Ethics Committee in Research, Office of Vice Chancellor for Education, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan Hamadan Hamadan Iran (Islamic Republic of)