A Dose-response Study to Determine the Right Dosage of Su... | NCT07477132

ID	Type	Description	Link
2025-521946-82-00	EU Trial (CTIS) Number

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Infants < 24 months old	Experimental		Drug: Sugammadex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex	Drug	Sugammadex titration as an antagonist agent of rocuronium in infants < 24 months old undergoing surgery. In post anesthesia care room 0.2mg/kg of sugammadex will be administered every 3 +/-1 min while monitoring the residual neuromuscular blockade with an EMG based device.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.	The total dosage is obtained by adding each titration dosage of 0.2mg/kg every 3 +/-1 min to obtain a TOF ration of > 90%. The analysis will be conducted in three age categories (<6 months, 6-12 months, 12-24 months) and according to the depth of neuromuscular blockade before reversal (TOF count < 2/4 and TOF count ≥ 2/4).	From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

Secondary Outcomes

Measure	Description	Time Frame
Compare among the three age groups (<6 months, 6-12 months, 12-24 months): the doses of sugammadex required to achieve complete reversal of neuromuscular blockade, the percentage of subjects for whom the required dose was lower than the recommended dose	The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).	From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

Eligibility Module

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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms