Baby drug dosing study aims to prevent post-surgery breathing problems
NCT ID NCT07477132
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will find the correct dose of sugammadex, a drug that reverses muscle relaxants, for infants under 2 years old. About 99 babies having non-emergency surgery will receive small, increasing doses until their muscle function returns. The goal is to ensure safe and complete reversal, reducing the risk of breathing difficulties after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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1 month to 24 months
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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 the time of surgical care. * Child suspected of having,or with a family history of, malignant hyperthermia. * Child suspected of having, or with a known allergy to, the medications used in the study (rocuronium, sugammadex) or any of their respective excipients. * Child expected to require mechanical ventilation at the end of the surgical procedure. * Child receiving, at the time of inclusion, regular treatment with medications that may interfere with the treatments used in this study: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine. * Minor holders of parental authority, or children under guardianship or curatorship.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Centre Hospitalier universitaire Caen Normandie
Caen, 14000, France