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

Phase 4Not Yet RecruitingNCT07477132

University Hospital, Caen99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Curarization, Postoperative Residual

Interventions

Eligibility

Sex: ALLMin age: 1 MonthMax age: 24 Months

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).