Remote Preconditioning and Myocardial Protection

Assiut University

Status and phase: Completed; Phase 2

Conditions: Congenital Heart Disease

Treatments: Drug: Sevoflurane plus remote ischemic preconditioning; Drug: Total intravenous anesthesia plus remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02877238

IIRB0000871234

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Sevoflurane plus remote ischemic preconditioning

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Total intravenous anesthesia plus remote ischemic preconditioning