Remote Preconditioning and Myocardial Protection

Study Overview
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Brief Summary
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Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

Detailed Description
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The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Official Title
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Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Drug: Sevoflurane plus remote ischemic preconditioning
* Drug: Total intravenous anesthesia plus remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass Exclusion Criteria: Previous cardiac surgery Urgent or emergent cases Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles | Drug: Sevoflurane plus remote ischemic preconditioning<br>* Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning<br>* Other names: Group A;|
| Active Comparator: Group B<br>anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles | Drug: Total intravenous anesthesia plus remote ischemic preconditioning<br>* Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin I levels | The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning. | within first 24 hours after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest inotropic score during the first 24 hours after cardiac surgery | Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery. The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery | within first 24 hours after cardiac surgery | 
| Mortality at 30 days | Proportion of patients who dies within 30 days of their surgical repair | 30 days | 
| Cardiac function | Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation | within first 24 hours of cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning, sevoflurane, total intravenous anesthetic