Minimally Invasive Pediatric Cardiac SurgeryTOFNCT07798011
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
An observational study of Minimally Invasive Pediatric Cardiac Surgery and Pediatric Cardiac Surgery, run by Dr. Nguyen Thi Thu Hang at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery, Early Extubation Pathway
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Dec 2025to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam National Children's Hospital (VNCH)
Hanoi, 100000
Nguyen Hang, Medical Doctor, +84 96 215 82 85, hang.nguyen@nch.gov.vn
Ba Tuan Nguyen, Medical Doctor, PhD, Nguyenbatuan@hmu.edu.vn
About this study
Official title: Precision Neuromuscular Management: Quantitative TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Pediatric Minimally Invasive Cardiac Surgery (A Prospective Observational Cohort Study)
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.
Read the detailed description
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:
- Compare neuromuscular recovery, resource utilization, and adverse events between quantitative TOF-guided sugammadex administration and monitored spontaneous recovery.
- Identify factors associated with successful early tracheal extubation following pediatric minimally invasive cardiac surgery.
- Conditions
- Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery, Early Extubation Pathway, TOF-Guided Sugammadex Administration, ASD - Atrial Septal Defect
- Being tested
- Sugammadex
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| TOF-Guided Sugammadex Cohort | 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. Receives: Drug: Sugammadex | |
| Monitored Spontaneous Recovery Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tracheal Extubation
Time interval from the cessation of anesthetic maintenance agents (end of surgery) to successful tracheal extubation meeting predefined clinical criteria.
Measured: Up to 24 hours post-surgery.
Secondary outcomes (3)
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.
Measured: Perioperative/Periprocedural
Administered Sugammadex Dose
The precise dose of sugammadex administered, calculated in mg/kg, based on the TOF-guided clinical decision.
Measured: 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.
Measured: From enrollment to hospital discharge in 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start4 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Pediatric Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nguyen Thi Thu Hang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Nguyen Thi Thu Hang, National Children's Hospital, Vietnam
- Investigators
- Nguyen Huu Tu, Professor, Study chair, Hanoi Medical University (HMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798011
- Sponsor's protocol ID
- 6524/QĐ-ĐHYHN
- Acronym
- TOF
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.