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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort evaluates a precision neuromuscular management strategy in children undergoing minimally invasive congenital heart surgery. The approach combines enhanced recovery pathways with early extubation goals, aiming to reduce ICU time and resource use. Sugammadex is used to rapidly reverse neuromuscular blockade guided by train-of-four monitoring. The setting is a high-volume pediatric center in Vietnam, where delays in extubation are common due to residual blockade and resource constraints. Outcomes focus on safety, timing of extubation, ventilation duration, and ICU utilization.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vietnam National Children's Hospital (VNCH)
  Hanoi, Vietnam Recruiting

Study contacts

• Study coordinator: Nguyen Thi Thu Hang, Medical Doctor
• Email: hang.nguyen@nch.gov.vn
• Phone: +84 96 215 82 85

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.