Not Yet RecruitingPhase 4

A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old

France99 participantsStarted 2026-03-30

Plain-language summary

Sugammadex is a drug used more and more frequently in infants as a rocuronium' s reversal agent. It has multiples benefits over other reversal agents such as a rapid onset of action and a complete reversal no matter how deep is the neuromuscular blockade. The dosage of sugammadex used in current clinical practice is the same as in adults based on empirical evidence. Futhermore some multricentric studies showed that that dosage might not be appropriate for infants younger than 2 years old. The goal of this study is to determine the correct dosage of sugammadex to use in infants younger than 2 years old.

Who can participate

Age range

1 Month – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Child, male or female, aged \< 24 months. * American Society of Anesthesiologists (ASA) Physical Status Class I or II. * Non-cardiac and non-emergency surgical procedure, or relative emergency (\>12 h) requiring neuromuscular blockade with rocuronium and reversal with sugammadex. * Surgical procedure allowing neuromuscular monitoring at the adductor pollicis muscle. * Child covered by a social security regiment. * Written informed consent signed by the holder(s) of parental authority. * French-speaking holder(s) of parental authority. Exclusion Criteria: * Child who received or will receive toremifene or fusidic acid within 24 hours before or after administration of the study treatments (rocuronium, sugammadex). * Use of two different neuromuscular blocking agents during the procedure. * Failure to calibrate the Train-of-Four (TOF) qualitative count (TOFc) and quantitative ratio (TOFr). * Non-compliance with the titrated administration protocol of sugammadex and TOF monitoring during the study. * Use, during the procedure, of medications that may interfere with the study treatments: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine, or continuous IV lidocaine. Non inclusions criteria : * Emergency requiring care in the operating room within \< 12 hours. * Child weighing more than 20 kg. * Premature child: \< 37 weeks gestational age at birth. * Suspected or diagnosed neuromuscular disorder at th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.

Timeframe: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

Trial details

NCT IDNCT07477132

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

View on ClinicalTrials.gov More Curarization, Postoperative Residual trials