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IRCT20210710051837N1 IRCT 2021-10-18 Mashhad University of Medical Sciences The effect of Dexmedetomidine on myocardial protection in patients undergoing Mitral valve replacement/ repair The effect of aortic root infusion of Dexmedetomidine before de-clamping of the aorta on myocardial protection in patients undergoing Mitral valve replacement/ repair 2021-07-23 anticipated 56 Complete https://irct.ir/trial/57484 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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: Subjects, Evaluators and Analysts will be unaware of the solutions administered to the aortic roots of the intervention and control groups. As we will define the syringe containing the solutions with the labels A and B, and the Subjects, Evaluators and Analysts are not aware of the contents of the syringe. 3 The effect of aortic root infusion of Dexmedetomidine before de-clamping of the aorta on myocardial protection in patients undergoing Mitral valve replacement/ repair. Intervention 1: Intervention group: At the end of the surgical procedure, before removing the aortic clamp, at the root of the aorta of patients, using a cardioplegia needle, a solution of dexmedetomidine with a concentration of 4 μg / ml, at a rate of 1 μg / kg / h, for 10 minutes, Is infused. Intervention 2: Control group: At the end of the surgical procedure, before removing the aortic clamp, in the aortic root of patients, using a cardioplegia needle, 0.9% sodium chloride solution at a rate of 1 ml / kg / hour for 10 minutes infusion will be. Yes - There is a plan to make this available What will be shared: Will be published as an article When: One year To whom: Researchers and Experts Conditions: it would be possible after getting permission from undersecretary of research Where to obtain: send email to Hajipouraf981@mums.ac.ir How to obtain: After requesting, the file will be sent in Excel or Spss. Comments:
public Fateme Hajipour Aghmashhadi
Edalat Alley, Aghapour Alley, Shahid Ghasemi Ave, Emam Reza Blvd, Sari Town
Sari Iran (Islamic Republic of) 4817987548 +98 11 3328 0646 Hajipour_atena@yahoo.com Mashhad University of Medical Sciences scientific Fateme Hajipour aghmashhadi
Edalat alley, Shahid Ghasemi Ave, Emam Reza blvd, Sari Town
Sari Iran (Islamic Republic of) 4817987548 +98 11 3328 0646 Hajipour_atena@yahoo.com 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 Supraventricularor ventricular dysrhythmias History of heart surgery Nephropathy following the use of contrast agent (CIN) Hypercapnic or hypoxic Respiratory failure Patients with a history of Stroke and TIA Patients with a history of Coagulopathy Use of an intra-aortic balloon pump (IABP) before and during surgery Use of vasopressor before surgery Patient dissatisfaction to participate in the study The presence of any pathological disorder leads to the release of inflammatory cytokines Cardiopulmonary arrest before, during and after surgery 105.9 Mitral (valve) disorder (chronic) NOS Prevention Prevention Intervention group: At the end of the surgical procedure, before removing the aortic clamp, at the root of the aorta of patients, using a cardioplegia needle, a solution of dexmedetomidine with a concentration of 4 μg / ml, at a rate of 1 μg / kg / h, for 10 minutes, Is infused. Control group: At the end of the surgical procedure, before removing the aortic clamp, in the aortic root of patients, using a cardioplegia needle, 0.9% sodium chloride solution at a rate of 1 ml / kg / hour for 10 minutes infusion will be. 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 outputs. Timepoint: The first 6 hours, the first 12 hours and 24 hours after the operation. Method of measurement: By catheterization and viewing the urinary bag. 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 2021-07-12 Ethics committee of Mashhad University of Medical Sciences East door of the University Campus, Azadi Square, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)