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IRCT20240527061915N1 IRCT 2024-07-08 Arak University of Medical Sciences The prophylactic effect of adding magnesium to metoral in reducing coronary AF Comparing the prophylactic effect of adding magnesium to Metoral in reducing atrial fibrillation after coronary artery bypass graft surgery 2024-06-21 anticipated 102 Complete https://irct.ir/trial/77107 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, CABG candidate patients referred to Amirulmomenin Hospital who meet the inclusion criteria and will be electively subjected to open heart surgery will be divided into two equal groups of magnesium + Metoral and Metoral. In this study, permutation random block method will be used for randomization. For this purpose, blocks of 6 will be used. In each block, the letter M (Metoral) is written on three cards and the letter S (Magnesium Sulfat) is written on three cards. Some of the selected random blocks of 6 are as follows: SMSMMS, SSMSMM, MSSMMS, SMSMSM, MSSMMS, MSMMSS, SMMMSS, MSSMMS, SMMSSM, SSMSMM. (For example, the method of random allocation in a block of 6 SMSMMS is as follows: the first patient to treatment S, the second patient to treatment M, the third patient to treatment S, the fourth patient to treatment M, the fifth patient to treatment M and the sixth patient to treatment S are allocated by accident, Blinding description: The aforementioned study is a double-blind study in which CABG candidate patients who meet the inclusion criteria are included in the study after obtaining informed consent, but it does not matter which of the study groups (Metoral and Metoral + magnesium) they are in. They don't know. Also, the mentioned drugs in 2 groups will be prepared by the anesthesiologist (design consultant) in the same shape, size and volume, and labels 1 and 2 will be placed on them. Then the said syringes will be given to the anesthesiologist in charge of the plan, who does not know the type of groups, to be injected to the patients. Also, the intern in charge of the project, who is responsible for the questionnaires of the project, and the data analyst, do not know about the studied groups, so the study will be double-blind. 3 All CABG candidate patients referred to Amirul Mominin Hospital. Intervention 1: Intervention group: Metoral + magnesium (1-3 mg⁄kg) per hour Metoral equivalent to 3 cc and 2 g of menium equivalent to 4 cc are injected and (by 2 5 cc syringes). Intervention 2: Control group: (Metoral) 1-3 mg⁄kg per hour Metoral equivalent to 3 cc and 4 cc of distilled water (using 2 5 cc syringes) same shape and same color as the first group. 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 There is no further information
public Alireza Kamali
Faculty of Medicine, Basij Square, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3520 AliKamaliir@yahoo.com Arak University of Medical Sciences scientific Alireza Kamali
Faculty of Medicine, Basij Square, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3520 AliKamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All CABG candidate patients referred to Amirul Mominin Arak Hospital All patients candidates for elective operations The age of patients between 35-75 years All patients are candidates for CABG only All patients who are operated with that pump All patients with informed consent to participate in this study The average duration of surgery is maximum 7 hours All patients who do not have heart valve repair surgery with CABG ASAⅢ,Ⅳ patients Patients who are not allergic to Metoral-Magnesium All patients who have acid-base disorders resistant to treatment before surgery 35 years 75 years Both Patients who suffer cardio-respiratory arrest during surgery Patients who do not agree to continue the study or cooperate All CABG candidate patients who require valve repair during surgery All patients who, after the induction of anesthesia, the surgeon decides to perform surgery with the pump OFF All patients who have acid-base disorders resistant to treatment before surgery T82 Complications of cardiac and vascular prosthetic devices, implants and grafts Treatment - Drugs Treatment - Drugs Intervention group: Metoral + magnesium (1-3 mg⁄kg) per hour Metoral equivalent to 3 cc and 2 g of menium equivalent to 4 cc are injected and (by 2 5 cc syringes) Control group: (Metoral) 1-3 mg⁄kg per hour Metoral equivalent to 3 cc and 4 cc of distilled water (using 2 5 cc syringes) same shape and same color as the first group Occurrence of atrial fibrillation or other arrhythmias after surgery. Timepoint: 72 hours after the operation. Method of measurement: Monitoring and examination of patients will be used in open heart ICU. Mortality and morbidity rate of patients. Timepoint: 72 hours after the operation. Method of measurement: Monitoring and examination of patients in open heart ICU. Arak University of Medical Sciences Approved 2024-05-05 Ethics committee of Arak University of Medical Sciences Sardasht, Basij Square, University Complex of the Great Prophet (PBUH), Arak Arak Markazi Iran (Islamic Republic of)