The effect of Dexmedetomidine added to Del-Nido cardioplegic solution on the myocardial protection in pediatrics undergoing congenital heart defects surgery

Determining the effect of adding dexmedetomidine to Del-Nido's cardioplegia on myocardial protection in children undergoing congenital heart surgery.

Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 2 on 60 patients. The generation of random allocation sequence was done using the randomized block method and using www.randomization.com.

Cardiac Surgery Center of Imam Reza Hospital, Mashhad, Iran. After adding dexmedetomidine to the cardioplegia in the intervention group , to check the effect of the drug in protecting the myocardium, the lactate level of the coronary sinus are checked . Serum levels of TPI and CK-MB are controlled . After obtaining the consent of the patients and their entry into the project, all patients, treatment staff, surgical team and the biostatistics specialist are unaware of the placement of patient in the intervention or control group.

entering: pediatric patients between the ages of 1 month and 6 years who were referred to Imam Reza Cardiac Surgery Center to surgery for congenital heart defects with RACHS=1 RACHS=2, who have parental consent to participate in the study not entering : lack of parental consent to enter the study, coagulation disorders before surgery, liver dysfunction with increased SGOT, SGPT before surgery, presence of kidney diseases

In the intervention group, dexmedetomidine at the rate of 50 μg/ml per 500 ml of Del-Nido cardioplegia will be added to the said solution. The infusion of cardioplegic solution will continue until complete cardiac arrest. In the control group, before administering the cardioplegia , one ml of 0.9% sodium chloride will be added to the said solution for every 500 ml of Del-Nido cardioplegia.

Coronary sinus lactate level Troponin-I and CK-MB serum levels

The coded statistical data in two groups using del Nido cardioplegia with dexmedetomidine and using del nido cardioplegia without dexmedetomidine (A and B respectively) will be subjected to statistical analysis by a biostatistician who will know how the process is carried out. The study is uninformed. In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 10 blocks of size 4 and 10 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks with two sizes are 1: AB and 2: BA. The list of blocks with size four are: 1: AABB, 2: ABBA, 3: BBAA, 4: BAAB, 5: BABA, 6: ABAB. To select blocks of size 2, 10 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 10 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4, and if the selected number is 2, then the second block and so on for other blocks. are selected

The coded statistical data in two groups using Del-Nido cardioplegia with dexmedetomidine and using Del-Nido cardioplegia without dexmedetomidine (A and B respectively) will be subjected to statistical analysis by a biostatistician who doesn't know how the process is carried out. In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 10 blocks of size 4 and 10 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks with two sizes are 1: AB and 2: BA. The list of blocks with size four are: 1: AABB, 2: ABBA, 3: BBAA, 4: BAAB, 5: BABA, 6: ABAB. To select blocks of size 2, 10 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 10 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4, and if the selected number is 2, then the second block and Similarly, other blocks are selected . The generated allocation sequence is placed in sealed envelopes and will be reopened when the patients enter the plan. Patients will not know about their placement in each of the A and B groups. All the nursing staff, anesthesia team, perfusionist and surgeon who are responsible for the care and treatment of the patient will not know about the placement of the patient in each of the A and B groups. Based on the type of envelope, patients will be placed in one of the intervention or control groups. After that, the researcher will provide syringes labeled A (dexmedetomidine) or B (isotonic saline) to the perfusionist to add to the Del-Nido cardioplegia solution.