NCT07798011 Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 80 participants in total. It began in 2025-12-04 with a primary completion date of 2026-12-31.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. * Intraoperative neuromuscular blockade maintained using rocuronium. * Continuous intraoperative quantitative train-of-four (TOF) monitoring applied and calibrated. * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * 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. * Intraoperative surgical complications requiring conversion from a right mid-axillary thoracotomy to an open median sternotomy. * Intraoperative events mandating delayed extubation for patient safety (e.g., severe hemodynamic instability, massive hemorrhage, or refractory arrhythmias). * Inability to establish or maintain reliable quantitative TOF monitoring data during the procedure.

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