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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-24
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sugammadex

Treatment groups

99 Participants
are divided into 1 treatment group

Sponsors and collaborators