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

29 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

80

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Wietnam
      • Hanoi, Wietnam, 100000
        • Rekrutacyjny
        • Vietnam National Children's Hospital (VNCH)
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Truong Ly Thinh Nguyen, A/Professor

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to Tracheal Extubation
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to TOF Ratio >/= 0.90
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Dr. Nguyen Thi Thu Hang

Śledczy

  • Krzesło do nauki: Nguyen Huu Tu, Professor, Hanoi Medical University (HMU)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 grudnia 2025

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

31 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

18 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

1 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 6524/QĐ-ĐHYHN

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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