The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 10, 2022

Primary Completion Date

April 10, 2023

Study Completion Date

June 10, 2023

Conditions
Congenital Heart Disease in ChildrenCardiopulmonary BypassTetralogy of Fallot
Interventions
DRUG

Dexmedetomidine Hcl 100 Mcg/mL Inj

Priming dose of 0.5 mcg/kg in a 5 ml syringe mixed in priming fluid and 0.25 mcg/kg/hour DEX infusion diluted in 0.9% NaCl 20 ml in a 20 ml syringe administered to the CPB reservoir with an infusion rate of 10 ml/hour

DRUG

Placebo

Priming dose of NaCl 0.9% in a 5 ml syringe mixed in priming fluid and NaCl 0.9% 20 ml in a 20 ml syringe administered to the CPB reservoir with an infusion rate of 10 ml/hour

Trial Locations (1)

11420

National Cardiovascular Center Harapan Kita Hospital Indonesia, Jakarta

All Listed Sponsors
lead

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER