MedTrace Logo

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

NCT07798011 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-09-01

No results posted yet for this study

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 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.

Conditions

  • Minimally Invasive Pediatric Cardiac Surgery
  • Pediatric Cardiac Surgery
  • Early Extubation Pathway
  • TOF-Guided Sugammadex Administration
  • ASD - Atrial Septal Defect

Interventions

DRUG

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).

Sponsors & Collaborators

  • Dr. Nguyen Thi Thu Hang

    lead OTHER

Principal Investigators

  • Nguyen Huu Tu, Professor · Hanoi Medical University (HMU)

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07798011 on ClinicalTrials.gov