A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 主要终点
- Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
研究概览
简要总结
The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).
Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.
排除标准
- •Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.
研究组 & 干预措施
0.45 mg/kg Zemuron
0.45 mg/kg Zemuron
干预措施: Rocuronium bromide (Zemuron) (Drug)
0.6 mg/kg Zemuron
0.6 mg/kg Zemuron
干预措施: Rocuronium bromide (Zemuron) (Drug)
1.0 mg/kg Zemuron
1.0 mg/kg Zemuron
干预措施: Rocuronium bromide (Zemuron) (Drug)
结局指标
主要结局
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
时间窗: during surgery
次要结局
- Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score(during and after surgery)