跳至主要内容
临床试验/NCT06246331
NCT06246331招募中不适用

An Observational Study on the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection Administered for Reversal of Neuromuscular Blockade in Patients Receiving General Anesthesia

Hanlim Pharm. Co., Ltd.1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
1
主要终点
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)

研究概览

简要总结

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

详细描述

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

  • Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
  • Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over 19 years of age
  • Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

排除标准

  • Pregnant women or nursing women
  • Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection

结局指标

主要结局

Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)

时间窗: after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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