The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percent of Patients With Monitorable of Motor Evoked Potentials
研究概览
简要总结
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
详细描述
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring
排除标准
- •Allergy to dexmedetomidine, propofol
- •Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
- •Hepatic disease
研究组 & 干预措施
High dose dexmedetomidine
Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min
干预措施: Dexmedetomidine (Drug)
Low dose dexmedetomidine
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Percent of Patients With Monitorable of Motor Evoked Potentials
时间窗: During a single surgery for the duration of the operation
Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.
次要结局
未报告次要终点