Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- EMG changes
研究概览
简要总结
This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients less than 18 years of age
- •American Society of Anesthesiologists classification (ASA) 1-4
- •Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim
排除标准
- •Patients less than 28 days old
- •Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
- •Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- •Edematous patients
研究组 & 干预措施
Rocuronium infusion
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
干预措施: TetraGraph (Device)
结局指标
主要结局
EMG changes
时间窗: During the surgery (2-8 hrs.)
Changes in the amplitude of the evoked response of the muscles
Maximum dose of rocuronium
时间窗: During the surgery (2-8 hrs.)
The maximum dose of rocuronium administered by a continuous infusion to maintain one twitch of the train of four (TOF)
次要结局
未报告次要终点
研究者
Joseph D. Tobias
Chief, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital