An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron® in Pediatric and Adolescent Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- Total Dose of Zemuron (Rocuronium) Administered
研究概览
简要总结
The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation 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).
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 are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).
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 trials will not be allowed to enter.
研究组 & 干预措施
Rocuronium bolus maintenance
Rocuronium bolus maintenance
干预措施: Rocuronium bolus maintenance (Drug)
Rocuronium continuous infusion maintenance
Rocuronium continuous infusion maintenance
干预措施: rocuronium continuous infusion maintenance (Drug)
结局指标
主要结局
Total Dose of Zemuron (Rocuronium) Administered
时间窗: during surgery
Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \[TOF\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \[PP\] data set)
次要结局
- Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))
- Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))
- Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))