Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Sevoflurane plus remote ischemic preconditioning
- Conditions
- Congenital Heart Disease
- Sponsor
- Assiut University
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Troponin I levels
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Sayed Kaoud Abd-Elshafy
Associate profossor of anesthesia
Assiut University
Eligibility Criteria
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
Arms & Interventions
Group A
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
Intervention: Sevoflurane plus remote ischemic preconditioning
Group B
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
Intervention: Total intravenous anesthesia plus remote ischemic preconditioning
Outcomes
Primary Outcomes
Troponin I levels
Time Frame: within first 24 hours after cardiac surgery
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.
Secondary Outcomes
- Mortality at 30 days(30 days)
- Highest inotropic score during the first 24 hours after cardiac surgery(within first 24 hours after cardiac surgery)
- Cardiac function(within first 24 hours of cardiac surgery)