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IRCT20180428039456N1 IRCT 2019-07-26 Esfahan University of Medical Sciences The effect of Esmolol before cardioplegia and as a combination in cardioplegia on biochemical markers of myocardial injury in patients undergoing coronary artery bypass graft surgery The effect of Esmolol before cardioplegia and in the cardioplegic solution on the myocardial injury biomarkers in coronary artery bypass graft surgery patients 2019-03-03 anticipated 280 Complete https://irct.ir/trial/31235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre- and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 280, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope, Blinding description: All of the involved investigators and researchers, participants, principle surgeon, technician of cardiopulmonary bypass machine, anesthesiologist, and other operation room staff will not know which A or B is intervention or placebo group. Only the pharaceutical company which manufacture the ampule which is contaning the active drug or steril normal saline knows that. 3 coronary Artery disease. Intervention 1: The intervention group receives esmolol hydrochloride (as 100 mg/10 ml vial, ESOCARD, SAMARTH life sciences PVT. LTD pharmaceutical Co. INDIA) during the operation. First, as a 2 mg/kg in central venous catheter just before starting the CPB. After 5 minutes, the patient will put on CPB. Half of the first dose (1 mg/kg) will then be infused with the cardioplegic solution after aortic cross-clamping. This dose will be repeated for the next doses of the cardioplegic solution during the surgery. Intervention 2: Control group: The control group received the same volume of normal saline (10 mL) from an exact vial (manufactured in the Afachemi Pharmaceutical Co. IRAN). 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 Mehran Shahzamani
Chamran Hospital, Salman farsi Ave , Isfahan
isfahan Iran (Islamic Republic of) 7346181746 +98 31 3260 0961 drshahzamani@yahoo.com Esfahan University of Medical Sciences scientific Mehran Shahzamani
Chamran Hospital, Salman farsi Ave , Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3260 0961 drshahzamani@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Only coronary bypass grafting surgery candidates due to coronary artery disease and atherosclerosis Left ventricular Ejection fraction between 45-60% Left ventricle end diastole Diameter (LVEDD) less than 60 mm Age above 18 years old Not having diabetes mellitus type 2 or consuming any oral hypoglycemic agents Not having severe systemic diseases (including any pulmonary, hepatic, renal, and musculoskeletal diseases or immune system illnesses) Not participating in any other studies Not having any confirmed arrhythmia or consuming any anti-arrhythmic agents (except beta-blockers) no limit no limit Both Not willing to participate in the study No need for emergency operation No history of inappropriate reaction to Esmolol Not received Esmolol over the past 30 days I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Placebo The intervention group receives esmolol hydrochloride (as 100 mg/10 ml vial, ESOCARD, SAMARTH life sciences PVT. LTD pharmaceutical Co. INDIA) during the operation. First, as a 2 mg/kg in central venous catheter just before starting the CPB. After 5 minutes, the patient will put on CPB. Half of the first dose (1 mg/kg) will then be infused with the cardioplegic solution after aortic cross-clamping. This dose will be repeated for the next doses of the cardioplegic solution during the surgery. Control group: The control group received the same volume of normal saline (10 mL) from an exact vial (manufactured in the Afachemi Pharmaceutical Co. IRAN). Average of cardiac biomarkers Troponin I, CK-MB and LDH. Timepoint: Measurement of biochemical markers of myocardial injury before and 4, 12, 24 and 48 hours after surgery. Method of measurement: Patient blood samples and laboratory measurements. Frequency of ventricular fibrillation during the heart re-beat. Timepoint: After unclamping the aorta. Method of measurement: Electrocardiogram. Hours of ICU stay. Timepoint: After the surgery. Method of measurement: hours documented in the charts. Duration of patient admission after surgery in hospital. Timepoint: Number of hospital admission days in the post-operative. Method of measurement: Follow patient. Need for inotropic drugs. Timepoint: Check the number of inotropes used. Method of measurement: Follow patient. Esfahan University of Medical Sciences Approved 2019-03-03 Ethics committee of isfahan university of Medical sciences Hezar jerib Ave,isfahan university of Medical sciences isfahan Isfehan Iran (Islamic Republic of)