RecruitingNCT07798011

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

Precision Neuromuscular Management: Quantitative TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Pediatric Minimally Invasive Cardiac Surgery (A Prospective Observational Cohort Study)


Sponsor

Dr. Nguyen Thi Thu Hang

Enrollment

80 participants

Start Date

Dec 4, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sugammadex for people with asd - atrial septal defect, early extubation pathway, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSugammadex

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

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NCT07798011


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