NCT03513406已完成3 期
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Time to return to a 90% Train of Four (TOF) neuromuscular twitch
研究概览
简要总结
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing burn surgery under general anesthesia
排除标准
- •Patients without a non-burned upper extremity
- •Renal insufficiency or failure
- •Sensitivity or hypersensitivity reaction to sugammadex
- •Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol
研究组 & 干预措施
Sugammadex
Active Comparator
Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.
干预措施: Sugammadex (Drug)
Neostigmine
Active Comparator
Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.
干预措施: Neostigmine (Drug)
Neostigmine
Active Comparator
Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
Time to return to a 90% Train of Four (TOF) neuromuscular twitch
时间窗: Within 24 hours after surgery
次要结局
- Time to discharge from the operating room(Within 24 hours after surgery)
- Time to endotracheal extubation(Within 24 hours after surgery)
研究者
研究点 (1)
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