Skip to content

Remote Preconditioning and Myocardial Protection

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02877238
Enrollment
91
Registered
2016-08-24
Start date
2016-08-31
Completion date
2017-05-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

remote ischemic preconditioning, sevoflurane, total intravenous anesthetic

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.

Interventions

DRUGSevoflurane plus remote ischemic preconditioning

Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning

DRUGTotal intravenous anesthesia plus remote ischemic preconditioning

Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Troponin I levelswithin first 24 hours after cardiac surgeryThe 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

MeasureTime frameDescription
Highest inotropic score during the first 24 hours after cardiac surgerywithin first 24 hours after cardiac surgeryInotrope 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
Mortality at 30 days30 daysProportion of patients who dies within 30 days of their surgical repair
Cardiac functionwithin first 24 hours of cardiac surgeryCardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026