A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China
试验速览
- 阶段
- 4 期
- 入组人数
- 6,090
- 试验地点
- 22
- 主要终点
- incidence of TOFr<0.9
研究概览
简要总结
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
详细描述
In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.
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
- Double (Participant, Care Provider)
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
- •Aged 18 or older
- •Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery
- •Willing to comply with all study procedures and provide signed and dated informed consent
排除标准
- •Allergic reaction to gel electrode
- •Neuromuscular disorders and hepatic or renal dysfunction
- •Scheduled to receive mechanical ventilation therapy
- •Involved in other clinical trials
- •Body position and surgical procedure affecting TOF-Watch SX normal function
研究组 & 干预措施
Vecuronium Bromide
Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
干预措施: Vecuronium Bromide (Drug)
cisatracurium
Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over.
干预措施: Cisatracurium (Drug)
rocuronium
Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
干预措施: Rocuronium (Drug)
结局指标
主要结局
incidence of TOFr<0.9
时间窗: From tracheal extubation to 1 minute after extubation
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
次要结局
- Incidence of TOFr<0.9(One minute after arriving at PACU)
- Incidence of TOFr<0.7(One minute after arriving at PACU)
研究者
Xinmin Wu
Clinical Professor
Peking University First Hospital