Can precision dosing of sugammadex help children breathe on their own sooner after heart surgery?

NCT ID NCT07798011

Disease control Sponsor: Dr. Nguyen Thi Thu Hang Source: ClinicalTrials.gov ↗

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study looks at children aged 2 to 18 having minimally invasive heart surgery to fix simple defects. Researchers compare two approaches: giving sugammadex in doses adjusted to real-time nerve monitoring, versus letting muscle relaxation wear off naturally. The goal is to see which method allows children to wake up and breathe without a ventilator sooner, which could speed recovery and reduce ICU time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sugammadex, a drug that reverses muscle relaxation after anesthesia, given in doses guided by real-time nerve monitoring.
What this could lead to: If it works, this approach could help children wake up and breathe on their own faster after heart surgery, shortening ICU stays and improving recovery.
What could go wrong: This is an observational study, not a randomized trial, so results may be influenced by patient differences. Sugammadex can cause allergic reactions or rare breathing issues.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial septal defect ventricular septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asd - atrial septal defect Early extubation pathway Minimally invasive pediatric cardiac surgery Pediatric cardiac surgery Tof-guided sugammadex administration

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can precision dosing of sugammadex help children breathe on their own sooner after heart surgery?

What the study statuses mean