This prospective observational cohort study evaluates a precision neuromuscular management strategy in pediatric patients undergoing minimally invasive cardiac surgery (MICS). Integrating MICS with enhanced recovery after surgery (ERAS) pathways has transformed perioperative management of congenital heart disease by enabling earlier recovery and reducing dependence on intensive care resources. A key component of these fast-track protocols is early tracheal extubation, preferably in the operating room (OR). Successful OR extubation promotes rapid return to spontaneous ventilation, decreases ICU utilization, and reduces the respiratory and hemodynamic risks associated with prolonged postoperative mechanical ventilation. To address critical perioperative challenges, including improving recovery outcomes and optimizing resource utilization in low- and middle-income country (LMIC) children's hospitals, this study compares the clinical efficacy, safety, and resource outcomes of quantitative train-of-four (TOF)-guided sugammadex administration with actively monitored spontaneous recovery.
Age older than 2 years and up to 18 years at the time of surgery.
Scheduled for elective minimally invasive cardiac surgery (MICS) via a right mid-axillary thoracotomy for the repair of simple congenital heart defects (e.g., Ventricular Septal Defect, Atrial Septal Defect).
Surgery requiring the use of cardiopulmonary bypass (CPB).
Deemed an appropriate clinical candidate for the institutional early-extubation (fast-track) pathway.
Patients arriving at the operating room already intubated or requiring preoperative mechanical ventilation.
Documented history of preexisting neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy) that alter the pharmacodynamics of neuromuscular blocking agents.
Known hypersensitivity or severe allergic reaction to sugammadex, rocuronium, or any of their excipients.
Severe preoperative hepatic dysfunction or renal impairment (e.g., estimated Glomerular Filtration Rate < [30] mL/min/1.73m²), which alters the clearance of sugammadex or muscle relaxants.
The study population consists of pediatric patients, aged 2 to 18 years, diagnosed with simple congenital heart defects (primarily Atrial Septal Defects and Ventricular Septal Defects). These patients are scheduled to undergo elective, minimally invasive cardiac surgery (MICS) utilizing cardiopulmonary bypass via a right mid-axillary thoracotomy approach. To be included in the cohort, patients must be deemed appropriate clinical candidates for the institution's established early-extubation (fast-track) cardiac anesthesia pathway, which mandates the routine use of objective anesthetic depth monitoring (e.g., SedLine/Patient State Index) and continuous quantitative train-of-four (TOF) neuromuscular monitoring. Patients arriving intubated, requiring complex open sternotomy, or presenting with preexisting neuromuscular, hepatic, or renal disease that alters the pharmacokinetics of neuromuscular blocking agents are excluded from the population.
Cohort
Prospective
Sugammadex
DrugIntravenous administration of sugammadex, with dosing (mg/kg) titrated to real-time quantitative train-of-four (TOF) monitoring data rather than standard fixed-weight dosing. (Assigned to Cohort 1).
Time to Tracheal Extubation
Time interval from the cessation of anesthetic maintenance agents (end of surgery) to successful tracheal extubation meeting predefined clinical criteria.
Time to TOF Ratio >/= 0.90
Time interval from the intervention (administration of sugammadex or start of spontaneous recovery observation) until the quantitative monitor displays a TOF ratio of \>/= 0.90.
Administered Sugammadex Dose
The precise dose of sugammadex administered, calculated in mg/kg, based on the TOF-guided clinical decision.
Specific Drug Cost Reductions
Calculated difference in drug acquisition costs between the tailored dose administered (or omitted in the spontaneous cohort) versus the standard theoretical 2.0 or 4.0 mg/kg dose.
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Dr. Nguyen Thi Thu Hang
Lead sponsor
National Children's Hospital, Vietnam
Sponsor institution
