A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients
A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.
To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 & 4E patients
Primary endpoint:
• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Jerusalem、以色列、91120
- 招聘中
- Hadassah Medical Organization
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首席研究员:
- Yoram Weiss, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA 4 AND ASA 4E patients
- Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -
Exclusion Criteria:
- Patients ASA 1-3 or 5
- Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
- Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- Hypersensitivity to the active substances or to any of the excipients of medications used
- Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
- Patients with severe hepatic impairment
- Age < 18 years
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Sugammadex (tradename Bridion)
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有源比较器:Traditional reversal or spontaneous recovery:
Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip.
Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
大体时间:24 hours
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24 hours
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次要结果测量
结果测量 |
大体时间 |
---|---|
Time to extubation - measure the difference in time from application of the surgical dressing until extubation.
大体时间:24 hours
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24 hours
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Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
大体时间:24 hours
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24 hours
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其他结果措施
结果测量 |
大体时间 |
---|---|
The effect of Sugammadex on cortisol levels
大体时间:72 hours
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72 hours
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合作者和调查者
调查人员
- 首席研究员:Yoram G Weiss, MD、Hadassah Medical Organization
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Sugammadex Reversal的临床试验
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Pusan National University Yangsan Hospital完全的
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Ankara City Hospital Bilkent尚未招聘
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University Health Network, TorontoMerck Sharp & Dohme LLC完全的
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Hospital do Divino Espírito Santo de Ponta Delgada完全的
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Federal University of São PauloHospital General Universitario Santa Lucia完全的