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IRCT20230218057443N1 IRCT 2023-06-13 Esfahan University of Medical Sciences The effect of N-acetylcysteine ​​on myocardial stress in coronary artery bypass surgery The effect of N-acetyl cysteine in Prime solution on reducing myocardial stress in coronary artery bypass surgery 2023-06-10 anticipated 40 Complete https://irct.ir/trial/68659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization of patients between two groups is done by Selde random method and using random assignment software (RAS). In this software, the total number of sample size (40 people) and the number of groups (two groups) are entered into the software. The output of the software includes a list that randomly distributes the numbers 1 to 40 in two groups. Patients are entered into one of the two groups according to the time of visiting the hospital and according to the mentioned list, so that the sample size reaches the required number in each group, Blinding description: In this study, the participants, clinical caregivers (laboratory, operating room personnel, nurses), those who evaluate the outcome and those who analyze the data are unaware of the type of drug received and these people do not know which the participant is in. The group (intervention/control) is located. 3 کاهش خونرسانی سرخرگ‌های قلب. Intervention 1: Intervention group: N-acetyl cysteine ​​ampoule at the rate of 20 mg per kilogram of body weight in Prime solution in the cardiopulmonary bypass circuit. Intervention 2: Control group: equivalent volume of intervention drug from normal saline as placebo in Prime solution in cardiopulmonary bypass circuit. 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 The release schedule is not clear
public Mehran Shahzamani
Mushtaq Ave ,Shahid Chamran Hospital
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3260 0961 b.baharifar1370@gmail.com Esfahan University of Medical Sciences scientific Mehran Shahzamani
Salman Farsi Ave
Isfahan Iran (Islamic Republic of) 1288814836 +98 31 3260 0961 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients candidates for CABG surgery informed consent age (40-70) years ejection fraction EF ≥ 50%) non-emergency patients, patients with stable hemodynamics patients who did not use ECMO and balloon pump before surgery 40 years 70 years Both I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Placebo Intervention group: N-acetyl cysteine ​​ampoule at the rate of 20 mg per kilogram of body weight in Prime solution in the cardiopulmonary bypass circuit. Control group: equivalent volume of intervention drug from normal saline as placebo in Prime solution in cardiopulmonary bypass circuit Troponin. Timepoint: Before surgery, immediately and eight hours after surgery. Method of measurement: Venous blood sample. CRP. Timepoint: Before surgery, immediately and 24 hours after surgery. Method of measurement: Venous blood sample. Duration of stay in ICU. Timepoint: Time of discharge from ICU. Method of measurement: patient file. Need for defibrillator shock during surgery. Timepoint: during surgery. Method of measurement: view. The need for a pacemaker during surgery. Timepoint: during surgery. Method of measurement: view. Esfahan University of Medical Sciences Approved 2023-05-31 Ethics committee of Isfahan University of Medical Sciences Isfahan, Salman Farsi Street, after Shahristan Bridge, Martyr Dr. Chamran Heart Hospital Isfahan Isfehan Iran (Islamic Republic of)