An observational study in Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery and Early Extubation Pathway, sponsored by Dr. Nguyen Thi Thu Hang. Recruiting at 1 site in Vietnam. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Dr. Nguyen Thi Thu Hang · Observational
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:
84 studies on the registry are indexed under Heart Septal Defects, Atrial; 21 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 28 observational studies indexed under Heart Septal Defects, Atrial.
Browse Heart Septal Defects, Atrial studies →This is the only study on the registry with Dr. Nguyen Thi Thu Hang as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric MICS patients whose attending anesthesiologist elected to administer sugammadex for NMB reversal, with the dose tailored to the precise depth of the neuromuscular block as measured by quantitative TOF monitoring.
Drug: Sugammadex
Pediatric MICS patients whose attending anesthesiologist elected to forego pharmacological NMB reversal based on quantitative TOF monitoring, allowing the patient to achieve extubation criteria through actively monitored spontaneous recovery.
Intravenous 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 frame: Up to 24 hours post-surgery.
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.
Time frame: Perioperative/Periprocedural
Administered Sugammadex Dose
The precise dose of sugammadex administered, calculated in mg/kg, based on the TOF-guided clinical decision.
Time frame: Intraoperative (at the time of NMB reversal).
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.
Time frame: From enrollment to hospital discharge in 10 days
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the published article, along with the study protocol and statistical analysis plan, will be made available to qualified researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available from 6 months to 36 months after article publication.
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal. Proposals should be directed to the corresponding author. To access the data, requesters must sign a data access agreement.
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