NCT07477132尚未招募4 期
Study to Determine the Dosage of Sugammadex as a Rocuronium Reversal's Agent in Infants Younger Than 24 Months Old
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Infants < 24 months old
Experimental
干预措施: Sugammadex (Drug)
结局指标
主要结局
Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.
时间窗: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
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).
次要结局
- 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))
研究者
研究点 (1)
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