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

NCT07477132 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 25-00352025-521946-82-00
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neuromuscular blocking agent; children; curarization

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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

  From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

• 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

  From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

• Describe, in all three patient group, the temporal evolution of the depth of neuromuscular blockade during the reversal procedure.

  From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

• 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.

  From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

• Identify adverse events related to the administration of sugammadex, such as recurarization or drug hypersensitivity.

  From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)

Study Arms (1)

Infants < 24 months old

EXPERIMENTAL

Drug: Sugammadex

Interventions

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.

Infants < 24 months old

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Minor holders of parental authority, or children under guardianship or curatorship.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier universitaire Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 17, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)