2025-521946-82-00招募中2 期
A DOSE-DETERMINATION STUDY OF SUGAMMADEX AS A ROCURONIUM DECURARIZATION AGENT IN CHILDREN UNDER 2 YEARS OF AGE
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Dose–response study aimed at comparing, with the recommended adult dose (0.6 mg/kg), the doses of sugammadex required to achieve complete reversal of neuromuscular block (TOFr > 90% assessed by electromyographic monitoring) in children under 24 months of age who received rocuronium.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Boys and girls aged < 24 months.
- •American Society of Anesthesiologists (ASA) Physical Status Classe 1 ou
- •Non-urgent non-cardiac surgical procedure or relative emergency >12h which will require curarisation with rocuronium and decurarisation with sugammadex.
- •Surgical procedure for neuromuscular monitoring of the adductor muscle of the thumb.
- •Beneficiary of a social security system
- •Signature of informed consent by the holder(s) of parental authority
- •French-speaking holder(s) of parental authority
排除标准
- •Emergency to be managed in the operating theatre within < 12 hours.
- •Children weighing over 20 kg
- •Premature infant: < 37 weeks gestational age at birth.
- •Neuromuscular pathology suspected or diagnosed at the time of surgery.
- •Children suspected of having or with a family history of malignant hyperthermia.
- •Children suspected of having or having an allergy to the drugs used in the study (rocuronium, sugammadex) or to one of their respective excipients.
- •Child who will benefit from mechanical ventilation after the surgical procedure.
- •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.
- •Parents who are minors, under guardianship or trusteeship
结局指标
主要结局
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.
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.
次要结局
- Total dose of sugammadex administered below the recommendations for the adult population: yes / no.
- Total dose of sugammadex administered greater than the recommendations for the adult population: yes / no.
- Measurements of curarisation levels (TOFc and, where appropriate, TOFr) before the first injection and after each new injection of sugammadex.
- ˗ 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.
- Intensity of initial block depth: TOFc < 2/4, TOFc ≥ 2/4.
- Total dose of rocuronium, in mg/Kg (induction + possible re-administrations).
- Time (in minutes) between the last administration of rocuronium and the first administration of sugammadex.
- ˗ 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%.
- Occurrence of adverse events related to the administration of sugammadex: recurarisation, respiratory events on awakening or in the ICU, drug hypersensitivity.
研究者
Investigateur Coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (1)
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