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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade. [Срок оценки: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Non inclusions criteria :

• 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.
• Child receiving, at the time of inclusion, regular treatment with medications that may interfere with the treatments used in this study: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine.
• Minor holders of parental authority, or children under guardianship or curatorship.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Centre Hospitalier universitaire Caen Normandie — Caen

Идентификаторы

NCT: NCT07477132 · 25-0035 · 2025-521946-82-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗