Anesthesia
Conditions
Brief summary
Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.
Interventions
DRUGHTK cardioplegia
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
DRUGCold Cadioplegia
as the will receive group cold Blood Cardioplegia in volume 20mL/kg given by antegrade route through an aortic route cannula and repeated 10mL/kg/dose every 25minutes at 8-12°C for maintenance. This technique considered the standard management in this age.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients with tetralogy of Fallot spectrum. * Sex (males and females) * Age 6 months- 5 years.
Exclusion criteria
* Persistent left SVC draining in the coronary sinus. * Mental or neurologic disorders. * Preoperative critically ill patients. * Parents or legal guardian refusal. * Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Vasoactive-Inotropic Score | From time of separation of cardioplumonary bypass till 24 hours post operative | Calculate the doses of vasoactive drugs used |
Countries
Egypt
Outcome results
None listed