Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- 50% effective dose
研究概览
简要总结
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
详细描述
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
- •American Society of Anesthesiologists Physical Status 1 or 2
排除标准
- •History of hypersensitivity to rocuronium or any anesthetics
- •Presence of cardiovascular or genitourinary disease
- •Presence of severe renal dysfunction or in need of dialysis
- •Presence of severe hepatic dysfunction or coagualtion disorder
- •Current state of administration of neuromuscular blocking agent on admission to operating room
- •Concurrent use of any medications that affect the activity of neuromuscular blocking agents
- •History of malignant hyperthermia
- •Refusal to enroll in the study by one or more parents
- •Presence of any other reasons that investigator regards inappropriate to enroll in the study.
研究组 & 干预措施
Study group
Sequential determination of dose according to previous participant's result and by chance.
干预措施: Sugammadex (Drug)
结局指标
主要结局
50% effective dose
时间窗: From start of sugammadex administration to 2 minute after end of administration
Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.
95% effective dose
时间窗: From start of sugammadex administration to 2 minute after end of administration
Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.
次要结局
- Pulse oximetry(From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours))
- Blood pressure(From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours))
- TOF result(From start of sugammadex administration to 2 minute after end of administration)
- Residual blockade(From start of sugammadex administration to 24 hours after end of administration)
研究者
Sang-Hwan Ji
Clinical Assistant Professor
Seoul National University Hospital