Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07477132
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
24 Months
Study:
NCT07477132
Study Brief:
Protocol Section:
NCT07477132