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IRCT20190901044663N1 IRCT 2020-07-08 Rajaie Cardiovascular Medical and Research Center Comparison of using Lidocaine versus Amiodarone for the prevention of tachy ventricular arrhythmias Comparison of using Lidocaine versus Amiodarone for the prevention of Tachy ventricular arrhythmias after removal of Aorta cross clamp during valvular heart surgery 2019-08-21 anticipated 60 Complete https://irct.ir/trial/41870 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: In this study, a block randomization method is used. Randomization unit is individual and the tool used to randomize is the closed envelope. Inside each envelope is the English letter A or B. Patients fall into the Amiodaron or Lidocaine group according to the word that came out of the envelop, Blinding description: The participant is unaware of the prescribed medication due to general anesthesia, and the data analyst, safety committee, and data monitor also do not have access to the checklist. N/A Condition 1: Ventricular tachycardia. Condition 2: Ventricular tachycardia. Intervention 1: Intervention group 1: Lidocaine plus Magnesium Sulfate; Lidocaine 2 mg / kg plus Magnesium Sulfate 30 mg/kg and normal saline will be administered up to a total volume of 25 ml using infusion pump 5 minutes before the cross-clamp is opened. Intervention 2: Intervention group 2: 300 mg Amiodarone plus Magnesium Sulfate 30 mg/kg and normal saline up to a total volume of 25 ml will be administered by infusion pump 5 minutes before the cross-clamp is opened. 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 Admission to the article has not yet been received
public Fateme Hesari
No.19, Sadat alley, Rajaie street, Shahid Ardestani town
Pishva Iran (Islamic Republic of) 3381916131 +98 21 3678 1654 hessari.fatteme@gmail.com Shahid Rajaee Cardiovascular Medical and Research Center scientific Fateme Hesari
No. 19, Sadat alley, Rajaie street, Shahid Ardestani town
Pishva Iran (Islamic Republic of) 3381916131 +98 21 3678 1654 hessari.fatteme@gmail.com Rajaie Cardiovascular Medical and Research Center Iran (Islamic Republic of) Patient consent to participate in the study 18 years of age or older No previous cardiac surgery No contraindication or severe allergy to amiodarone, Lidocaine and Magnesium Sulfate Normal serum levels of liver enzymes Serum creatinine levels are less than 2 mg / dL. 18 years no limit Both Transient cerebral ischemia or stroke Uncontrolled diabetes mellitus during study Carotid artery stenosis over 50% Uncontrolled hypertension Prevention Prevention Intervention group 1: Lidocaine plus Magnesium Sulfate; Lidocaine 2 mg / kg plus Magnesium Sulfate 30 mg/kg and normal saline will be administered up to a total volume of 25 ml using infusion pump 5 minutes before the cross-clamp is opened. Intervention group 2: 300 mg Amiodarone plus Magnesium Sulfate 30 mg/kg and normal saline up to a total volume of 25 ml will be administered by infusion pump 5 minutes before the cross-clamp is opened. Occurrence of ventricular tachyarrhythmias. Timepoint: During the bypass and 5 minutes before the cross-clamp opening. Method of measurement: Electrocardiograph. Ejection Fraction. Timepoint: 24 hours after intervention. Method of measurement: Echocardiography. Rajaie Cardiovascular Medical and Research Center Approved 2019-11-17 Shaheed Rajaie Cardiovascular Medical and Research Center Beside Mellat park; Niayesh Intersection; Valiasr street; Tehran Tehran Tehran Iran (Islamic Republic of)