SUGAMMADEX for Non-cardiac surgical procedure requiring neuromuscular blockade

Inclusion criteria

• {"criterion_text":"- Boys and girls aged < 24 months."}
• {"criterion_text":"- American Society of Anesthesiologists (ASA) Physical Status Classe 1 ou 2."}
• {"criterion_text":"- Non-urgent non-cardiac surgical procedure or relative emergency >12h which will require curarisation with rocuronium and decurarisation with sugammadex."}
• {"criterion_text":"- Surgical procedure for neuromuscular monitoring of the adductor muscle of the thumb."}
• {"criterion_text":"- Beneficiary of a social security system"}
• {"criterion_text":"- Signature of informed consent by the holder(s) of parental authority"}
• {"criterion_text":"- French-speaking holder(s) of parental authority"}

Exclusion criteria

• {"criterion_text":"- Emergency to be managed in the operating theatre within < 12 hours."}
• {"criterion_text":"- Children weighing over 20 kg"}
• {"criterion_text":"- Premature infant: < 37 weeks gestational age at birth."}
• {"criterion_text":"- Neuromuscular pathology suspected or diagnosed at the time of surgery."}
• {"criterion_text":"- Children suspected of having or with a family history of malignant hyperthermia."}
• {"criterion_text":"- Children suspected of having or having an allergy to the drugs used in the study (rocuronium, sugammadex) or to one of their respective excipients."}
• {"criterion_text":"- Child who will benefit from mechanical ventilation after the surgical procedure."}
• {"criterion_text":"- Children receiving, at the time of inclusion, regular treatment with drugs that interfere with the treatments used in this study: aminoglycosides, lincosamides, polymyxins, quinidine, magnesium salts, phenytoin, carbamazepine."}
• {"criterion_text":"- Parents who are minors, under guardianship or trusteeship"}

Primary endpoints

• {"endpoint_text":"- Total dose of sugammadex, in mg/Kg, to obtain complete decurarisation: TOFc 4/4 and TOFr ≥ 90%. The total dose is obtained by adding the sub-doses of 0.2 mg/Kg administered cumulatively every 3+/- 1 minute to each child until a TOFr >90% is obtained.","definition_or_measurement_approach":"Complete decurarisation defined as TOFc 4/4 and TOFr ≥ 90%. Total dose calculated by summing cumulative 0.2 mg/kg sub-doses given every 3 ± 1 minute until TOFr >90%."}

Secondary endpoints

• {"endpoint_text":"- Total dose of sugammadex administered below the recommendations for the adult population: yes / no.","definition_or_measurement_approach":"Binary assessment whether total sugammadex dose administered is below adult population recommendations."}
• {"endpoint_text":"- Total dose of sugammadex administered greater than the recommendations for the adult population: yes / no.","definition_or_measurement_approach":"Binary assessment whether total sugammadex dose administered is greater than adult population recommendations."}
• {"endpoint_text":"- Measurements of curarisation levels (TOFc and, where appropriate, TOFr) before the first injection and after each new injection of sugammadex.","definition_or_measurement_approach":"Serial measurements of TOFc and TOFr recorded before first injection and after each subsequent injection."}
• {"endpoint_text":"- ˗ Occurrence of recurarisation phenomena during the decurarisation procedure: yes / no. At each decurarisation measurement, a recurarisation phenomenon was defined as: - A decrease of at least 2 units in TOFc, for subjects who had a TOFc < 4/4 at the previous time; - A gross decrease of at least 20% in TOFr or a return to a TOFc < 4/4, for subjects with a TOFc = 4/4 at the previous time.","definition_or_measurement_approach":"Recurarisation defined as either a decrease ≥2 units in TOFc for those with prior TOFc <4/4, or a ≥20% decrease in TOFr or return to TOFc <4/4 for those with prior TOFc =4/4."}
• {"endpoint_text":"- Intensity of initial block depth: TOFc < 2/4, TOFc ≥ 2/4.","definition_or_measurement_approach":"Initial block depth categorized by TOFc <2/4 versus TOFc ≥2/4."}
• {"endpoint_text":"- Total dose of rocuronium, in mg/Kg (induction + possible re-administrations).","definition_or_measurement_approach":"Sum in mg/kg of rocuronium administered (induction plus any re-administrations)."}
• {"endpoint_text":"- Time (in minutes) between the last administration of rocuronium and the first administration of sugammadex.","definition_or_measurement_approach":"Elapsed time in minutes between last rocuronium dose and first sugammadex dose."}
• {"endpoint_text":"- ˗ Occurrence of post-complete recurarisation, up to 60 minutes after the last administration of sugammadex: yes / no. A recurarisation is defined by the measurement of a TOFc < 4/4 or a TOFr < 90% after having observed a TOFr> 90%.","definition_or_measurement_approach":"Occurrence within 60 minutes after last sugammadex dose of TOFc <4/4 or TOFr <90% after previously observing TOFr >90%."}
• {"endpoint_text":"- Occurrence of adverse events related to the administration of sugammadex: recurarisation, respiratory events on awakening or in the ICU, drug hypersensitivity.","definition_or_measurement_approach":"Recording incidence of adverse events potentially related to sugammadex: recurarisation, respiratory events on awakening or in PACU/ICU, hypersensitivity."}

France

Earliest CTIS Part Ii Submission Date

26-09-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

47

Number Of Sites

1

Number Of Participants

99

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France