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

Recruitingn/aAges 2 Years - 18 YearsAllDr. Nguyen Thi Thu Hang
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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/1.73mยฒ), 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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What it tests

  • Sugammadex
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Where

1 site
Vietnam National Children's Hospital (VNCH)
Hanoi, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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