Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Train of four ratio >0.9
研究概览
简要总结
Moderate and Deep neuromuscular blockade (rocuronium administered to a train of four count 0 and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in an already weakened population
详细描述
The Critically ill is a special population needing immediate and aggressive treatments and interventions. Neuromuscular blockade is frequently used to secure an airway, optimize ventilation/oxygenation in ARDS, aid in maintaining hypothermia in patients post-cardiac arrest. Muscle relaxants can also contribute to neuromuscular weakness in the critically ill which can be a devastating condition. Appropriate depth of neuromuscular blockade is important but unnecessary paralysis need to be avoided. Rocuronium is one of the most popular neuromuscular blockade agents used in the critically ill (1). Sugammadex is a modified γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular blocking agents rocuronium and vecuronium (2). Sugammadex results in rapid, predictable recovery from moderate and deep neuromuscular blockade. Sugammadex has been mostly studied and used in the surgical population but its use outside the operating room is still very relevant. The investigators set up to evaluate the potential benefit that may result from the reversal of NMB with sugammadex compared to neostigmine.
Objectives
In critically ill patients undergoing intubation receiving appropriate depth of NMB (moderate and deep blockade) the investigators will assess:
Primary objective:
- To determine if choice of reversal agent affects time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients requiring intubation in the intensive care unit
排除标准
- •Patients younger than 18 yr, to have known or suspected neuromuscular disease, allergies to medications to be used during intubation, a (family) history of malignant hyperthermia or severe renal insufficiency (glomerular filtration rate <30 ml/h) will not be eligible.
研究组 & 干预措施
Neostigmine
Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
干预措施: Neostigmine (Drug)
Neostigmine
Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
干预措施: Rocuronium (Drug)
Neostigmine
Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
干预措施: Glycopyrrolate (Drug)
Sugammadex
Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
干预措施: Sugammadex (Drug)
Sugammadex
Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
干预措施: Rocuronium (Drug)
结局指标
主要结局
Train of four ratio >0.9
时间窗: up to 12 weeks
time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio \>0.9
次要结局
未报告次要终点
研究者
Roupen Hatzakorzian, MD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre