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IRCT20210713051881N1 IRCT 2021-11-03 Mashhad University of Medical Sciences The effect of Dexmedetomidine on myocardial protection in patients undergoing Mitral valve replacement/ repair Evaluation of the effect of adding dexmedetomidine to del-Nido cardioplegia solution on myocardial protection in patients undergoing mitral valve replacement / repair 2021-11-22 anticipated 56 Complete https://irct.ir/trial/57542 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using the randomized block method and using the site www.randomization.com Block: This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. For this method, the volume of each block must first be determined ( Example of a quadruple block). Then write a list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers between one and 6 (Eg 1 4 5 and ...) and finally specify the treatment allocation list based on previous random numbers (AB AABB-BBAA-BABA-).} Allocation Concealment Allocation Method: The lottery is done using the envelope in the package, Blinding description: The subjects, evaluators and analysts will be unaware of the solutions prescribed for the cardipoegy of the intervention and control groups. We will define the syringe containing the solutions with labels A and B, and the subjects, evaluators and analysts are not aware of the contents of the syringe. 3 Evaluation of the effect of adding dexmedetomidine to del-Nido cardioplegia solution on myocardial protection in patients undergoing mitral valve replacement / repair. Intervention 1: Intervention group:Intervention group: Before administering the cardioplegia solution, a vial of 200 μg / ml dexmedetomidine (in a 2 ml syringe labeled A) per 500 ml of Del-Nido cardioplegia solution will be added to the solution. . The solution will contain dexmedetomidine at a concentration of 0.4 μg / ml. The infusion of the cardioplegia solution will be continued until complete cardiac arrest with the surgeon's advice. The amount and number of times the cardioplegia solution is administered will be recorded. Intervention 2: Control group: Before administering the cardioplegia solution, 1ml of 0.9% sodium chloride solution (in a 2 ml syringe labeled B) will be added to the solution for every 500 ml of the Del-Nido cardioplegia solution. The infusion of the cardioplegia solution will be continued until complete cardiac arrest with the surgeon's advice. The amount and number of times the cardioplegia solution is administered will be recorded. The perfusionist will be unaware of the contents of the prescribed solution. Yes - There is a plan to make this available What will be shared: It Will be published as an article When: One year To whom: Researchers and Experts Conditions: It would be possible after getting permission from the undersecretary of research Where to obtain: Send email to chahip981@mums.ac.ir How to obtain: After request, the file will be sent in Excel or Spss. Comments:
public Pedram Chahi
No. 41, Farhad Ave
Mashhad Iran (Islamic Republic of) 9185745637 +98 51 3760 3653 chahip981@mums.ac.ir Mashhad University of Medical Sciences scientific Pedram Chahi
No. 41, Farhad Ave
Mashhad Iran (Islamic Republic of) 9185745637 +98 51 3760 3653 chahip981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Candidate patients for mitral valve repair or replacement with ejection fraction above 40% 18 years no limit Both History of supraventricular dysrhythmias History of heart surgery Nephropathy following the use of contrast agent (CIN) Persistent respiratory problems Patients with a history of Stroke and TIA Patients with a history of Coagulopathy Use an intra-aortic balloon pump (IABP) before and during surgery Use vasopressor before surgery Patient dissatisfaction to participate in the study The presence of any pathological disorder leading to the release of inflammatory cytokines Cardiopulmonary arrest before, during and after surgery I34 Nonrheumatic mitral valve disorders Prevention Prevention Intervention group:Intervention group: Before administering the cardioplegia solution, a vial of 200 μg / ml dexmedetomidine (in a 2 ml syringe labeled A) per 500 ml of Del-Nido cardioplegia solution will be added to the solution. . The solution will contain dexmedetomidine at a concentration of 0.4 μg / ml. The infusion of the cardioplegia solution will be continued until complete cardiac arrest with the surgeon's advice. The amount and number of times the cardioplegia solution is administered will be recorded. Control group: Before administering the cardioplegia solution, 1ml of 0.9% sodium chloride solution (in a 2 ml syringe labeled B) will be added to the solution for every 500 ml of the Del-Nido cardioplegia solution. The infusion of the cardioplegia solution will be continued until complete cardiac arrest with the surgeon's advice. The amount and number of times the cardioplegia solution is administered will be recorded. The perfusionist will be unaware of the contents of the prescribed solution. Troponin I Assay. Timepoint: Before entering the operating room, In the first hour, 6 hours later, 12 hours later and 24 hours after entering the Intensive Care Unit. Method of measurement: Blood sample. Creatinine kinease _MB Assay. Timepoint: Before entering the operating room, In the first hour, 6 hours later, 12 hours later and 24 hours after entering the Intensive Care Unit. Method of measurement: Blood sample. The rate of urinary output. Timepoint: The first 6 hours, the first 12 hours and 24 hours after the operation. Method of measurement: By catheterization. CRP level. Timepoint: Before surgery, 6 hours after entering the Intensive Care Unit, 12 hours after and 24 hours after entering the Intensive Care Unit. Method of measurement: Blood sample. ESR level. Timepoint: Before surgery, 6 hours after entering the Intensive Care Unit, 12 hours after and 24 hours after entering the Intensive Care Unit. Method of measurement: Blood sample. Inotropic Score. Timepoint: In the Intensive Care Unit. Method of measurement: Inotropic score = ([dopamine + dobutamine]×1) + (milrinone×15) + ([epinephrine + norepinephrine + isoproterenol]×100). Mashhad University of Medical Sciences Approved 2021-06-15 Ethics committee of Mashhad University of Medical Sciences East door of the University Campus, Azadi Square, Mashhad Town۹۱۷۷۹۴۸۵۶۴ Mashhad Razavi Khorasan Iran (Islamic Republic of)