Recording of Intraoperative Spinal Cord Stimulation and Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in respiratory frequency
研究概览
简要总结
Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
排除标准
- 未提供
结局指标
主要结局
Change in respiratory frequency
时间窗: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Increase or decrease in respiratory frequency of 20% during or after stimulation
Change in respiratory tidal volume
时间窗: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Increase or decrease in respiratory tidal volume of 20% during or after stimulation
次要结局
- Change in heart rate(During intraoperative surgery during stimulation and within 2 minutes after stimulation)
- Change in blood pressure(During intraoperative surgery during stimulation and within 2 minutes after stimulation)
研究者
Daniel Lu, MD, PhD
Professor, Neurosurgery
University of California, Los Angeles