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

29 augustus 2026 bijgewerkt door: Dr. Nguyen Thi Thu Hang

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

80

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Werving
        • Vietnam National Children's Hospital (VNCH)
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Truong Ly Thinh Nguyen, A/Professor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: Sugammadex
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).
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Tracheal Extubation
Tijdsspanne: Up to 24 hours post-surgery.
Time interval from the cessation of anesthetic maintenance agents (end of surgery) to successful tracheal extubation meeting predefined clinical criteria.
Up to 24 hours post-surgery.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to TOF Ratio >/= 0.90
Tijdsspanne: Perioperative/Periprocedural
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.
Perioperative/Periprocedural
Administered Sugammadex Dose
Tijdsspanne: Intraoperative (at the time of NMB reversal).
The precise dose of sugammadex administered, calculated in mg/kg, based on the TOF-guided clinical decision.
Intraoperative (at the time of NMB reversal).
Specific Drug Cost Reductions
Tijdsspanne: From enrollment to hospital discharge in 10 days
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.
From enrollment to hospital discharge in 10 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dr. Nguyen Thi Thu Hang

Onderzoekers

  • Studie stoel: Nguyen Huu Tu, Professor, Hanoi Medical University (HMU)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 december 2025

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 augustus 2026

Eerst geplaatst (Werkelijk)

1 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 september 2026

Laatste update ingediend die voldeed aan QC-criteria

29 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6524/QĐ-ĐHYHN

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Data will be available from 6 months to 36 months after article publication.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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