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.
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 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.
Single group
Sugammadex
DrugSugammadex 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.
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).
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).
Detect the possible occurrence of electrical or clinical recurarization phenomena during the reversal procedure in children under 24 months of age, and evaluate their association with different parameters
Detect the possible occurrence of electrical or clinical recurarization phenomena during the reversal procedure in children under 24 months of age, and evaluate their association with: the initial depth of neuromuscular blockade, the total dose of rocuronium administered, and the time interval between the last dose of rocuronium and the first dose of sugammadex. The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
Describe, in all three patient group, the temporal evolution of the depth of neuromuscular blockade during the reversal procedure.
The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
Determine the incidence of recurarization (defined as the reappearance of neuromuscular blockade after a fully documented complete reversal) within 60 minutes following sugammadex-induced reversal in children under 24 months of age.
The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
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