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RECRUITING
NCT07798011

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

Sponsor: Dr. Nguyen Thi Thu Hang

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2025-12-04

Completion Date

2026-12-31

Last Updated

2026-09-01

Healthy Volunteers

No

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).

Locations (1)

Vietnam National Children's Hospital (VNCH)

Hanoi, Vietnam