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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD. Total correction of TOF was performed using a cardiopulmonary bypass (CPB) machine. However, the use of CPB has a negative effect that causes inflammation and myocardial injury. Myocardial protection in patients undergoing total correction of TOF surgery is more difficult than other cyanotic CHD due to a hypertrophic right ventricular condition. Dexmedetomidine (DEX) is a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of pro-inflammatory cytokines released. Thus, the administration of DEX can prevent myocardial necrosis and apoptosis, also reducing reperfusion injury when using CPB machines. Research related to the effectiveness of administering DEX as a myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery in Indonesia is less reported. The aim of this study is to determine the effectiveness of DEX as myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• The patient's parents or person in charge is willing to participate in the study

• Patients with classic TOF undergoing elective total correction cardiac surgery

• Aged 1 month - 18 years old

Exclusion Criteria:

• The patient experiences a change in the surgical plan from elective to immediate or emergency

• Patients with preoperative infection characterized by procalcitonin >0.5ng/mL

• Patients with impaired liver function characterized by an increase in Serum Glutamic Oxaloacetic Transaminase (SGOT)/Serum Glutamic Pyruvic Transaminase (SGPT) more than 1.5 times the upper limit of normal

• Impaired renal function characterized by creatinine > 2 mg/dL

• Patients with coagulation disorders characterized by International Normalized Ratio (INR) > 1.5

Drop-out Criteria:

• Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes

• Surgery requires more than two attempts of CPB

• Patient fails to wean from CPB

• Patient requires ECMO (Extracorporeal Membrane Oxygenator) postoperatively

• Patients with postoperative reperfusion injury characterized by pulmonary hemorrhage

• Patients with residual lesions in the form of moderate-severe pulmonary stenosis and moderate-severe pulmonary regurgitation.

• Patient dies on the operating table