NCT07477132

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

Study to Determine the Dosage of Sugammadex as a Rocuronium Reversal's Agent in Infants Younger Than 24 Months Old

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Curarization, Postoperative Residual

Interventions

Type	Name	Description
DRUG	Sugammadex	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.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-08-01
• Completion: 2027-10-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: France