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

Overview

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.

At the investigator's center, minimally invasive cardiac surgery (MICS) via a right mid-axillary approach for congenital heart defects such as ventricular septal defect (VSD) and atrial septal defect (ASD) accounts for approximately one-third of all pediatric cardiac surgeries requiring cardiopulmonary bypass (about 400 of 1,200 annual cases). In this high-volume setting, limited intensive care unit (ICU) bed availability creates a strong clinical imperative to facilitate early tracheal extubation, reduce mechanical ventilation duration, and shorten ICU length of stay. Early extubation, including extubation in the operating room (OR), requires adequate recovery of consciousness, spontaneous ventilation, and analgesia. Advances in anesthetic management, including rapidly cleared sedatives, multimodal analgesia, and regional anesthesia techniques, have substantially reduced the impact of sedation and opioid-related respiratory depression. Consequently, residual neuromuscular blockade has become a major physiological barrier to successful early extubation. In many pediatric cardiac centers in Vietnam, patients undergoing MICS are routinely transferred to the ICU with postoperative mechanical ventilation and without pharmacologic neuromuscular reversal. Even when surgical repair is uncomplicated and hemodynamics are stable, extubation is often delayed until spontaneous recovery from neuromuscular blockade occurs. Sugammadex provides rapid and effective reversal of rocuronium-induced neuromuscular blockade and has an established safety profile. However, resource constraints may limit routine use, and evidence supporting precision dosing strategies in pediatric MICS remains limited. Quantitative train-of-four (TOF) monitoring serves as the foundation of the institution's neuromuscular management strategy by objectively measuring the depth and recovery of neuromuscular blockade, enabling informed decisions regarding either targeted sugammadex administration or continued observation for spontaneous recovery. This precision-monitoring approach may facilitate earlier extubation while avoiding unnecessary reversal therapy and associated costs. This study is strictly observational. All patients receive standard care according to the institution's established early-extubation cardiac anesthesia pathway, which includes multimodal analgesia, processed electroencephalographic monitoring (SedLine/Patient State Index), and continuous quantitative TOF monitoring. The study does not alter perioperative management or influence the attending anesthesiologist's decision regarding neuromuscular reversal. Instead, it prospectively evaluates the clinical and resource outcomes associated with existing practice patterns. The investigators hypothesize that quantitative TOF-guided neuromuscular management will be associated with higher rates of successful early operating room extubation, shorter mechanical ventilation duration, reduced ICU resource utilization, and safe avoidance of unnecessary sugammadex administration in selected patients. Therefore, this prospective observational cohort study aims to: 1. Compare neuromuscular recovery, resource utilization, and adverse events between quantitative TOF-guided sugammadex administration and monitored spontaneous recovery. 2. Identify factors associated with successful early tracheal extubation following pediatric minimally invasive cardiac surgery.