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IRCT20201217049741N1 IRCT 2021-01-10 Shahid Rajaei Heart Hospital, Tehran Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass Assessing The Effects Of Mild And Moderate Hypothermia On The Cerebral Oxymetery In Acyanotic Congenital Heart Disease Under The Cardiopulmonary Bypass 2021-01-09 anticipated 64 Complete https://irct.ir/trial/53195 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assignment of individuals to study groups was done in a randomized block method using 4 blocks. This work was done with the relevant software by the professor of statistics. In each block, there were 2 people belonging to group A and two people belonging to group B, whose order was random and the blocks were selected using a table of random numbers, Blinding description: Patients' parents are given explanations about the study and the two groups to be studied, and then they are given consent to enter the study, but they are not told which group they are in. N/A Congenital Acyanotic heart disease. Intervention 1: Intervention group: Patients in the mild hypothermia group (32 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (first group 32 Degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion. Intervention 2: Intervention group: Patients in moderate hypothermia (28 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (28 degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion. 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 In case of a final decision, I will specify whether or not to publish.
public Mehran Jafarian
Valiasr St., Niayesh Intersection, Shahid Rajaei Heart Hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 mehran.jafarian1369@gmail.com Shahid Rajaei Cardiovascular Hospital, Tehran scientific Mehran Jafarian
Valiasr St., Niayesh Intersection, Shahid Rajaei Heart Hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 Mehran.jafarian1369@gmail.com Shahid Rajaei Cardiovascular Hospital, Tehran Iran (Islamic Republic of) Children 1 day to 14 years old undergoing surgery for Acyanotic congenital heart disease with pulmonary heart bypass Children weighing 5 to 20 kg No history of neurological diseases No hepatic or renal insufficiency (creatinine above 2 mg / dL) No preoperative anemia No history of preoperative cardiopulmonary resuscitation Parents' consent to participate in the research project 1 day 14 years Both Hemodynamic instability Emergency heart surgery Lower the temperature during operation to below the desired temperature Other Other Intervention group: Patients in the mild hypothermia group (32 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (first group 32 Degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion. Intervention group: Patients in moderate hypothermia (28 ° C) are treated as follows. The nasopharyngeal temperature will be maintained above 35 degrees for the time before the onset of cardiopulmonary bypass. For each child, 5 measurements are performed at different intervals: 1- at the time after induction of anesthesia (baseline value), 2- at the time of cooling up to 34 degrees Celsius, 3- at the time of the lowest level of cooling (28 degrees Celsius), 4- at reheating time (above 34 degrees Celsius), 5- after CPB completion. Cerebral oxygenation. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Based on the amount of INVOS. Blood lactate. Timepoint: 1- At the time after induction of anesthesia (baseline value), 2- At the time of cooling up to 34 degrees Celsius, 3- At the lowest level of cooling (first group 32 degrees Celsius), (second group 28 degrees Celsius), 4 - At the time of reheating (above 34 degrees Celsius), 5-after CPB. Method of measurement: Laboratory kits. Incidence of neurological complications. Timepoint: From postoperative time to discharge. Method of measurement: Based on patient records. Average intubation time. Timepoint: From the time of surgery to Extubation. Method of measurement: Based on patient records. Shahid Rajaei Heart Hospital, Tehran Approved 2020-01-25 Ethics Committee of Shahid Rajaei Heart Hospital, Tehran Valiasr St., the intersection of Niayesh Shahid Rajaei Heart Hospital Tehran Tehran Iran (Islamic Republic of)