Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity)
研究概览
简要总结
The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. This medication has numerous effects on the sensory nerve transmission which can theoretically have effects on the ability to accurately measure somatosensory evoked potentials.
详细描述
The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. Fosaprepitant is a drug commonly used to prevent post-operative nausea and vomiting, and works by inhibiting "substance P", which is found in the brain and spinal cord. Theoretically, fosaprepitant could interfere with nervous system recordings because of its effect on substance P,but it is not known if this actually occurs. The drug will be given after the patient has been anesthetized but before surgical incision so that if there are any changes on the intraoperative neuromonitoring signals they can only be attributed to fosaprepitant.
If fosaprepitant alters intraoperative neuromonitoring signals during surgical procedures under general anesthesia, it would be important because anesthesiologist's who administer this drug would want to give it at the beginning of surgery when changes in intraoperative neuromonitoring signals would be unlikely to mean that these changes were due to surgical damage to the nervous system.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a surgical procedure requiring general anesthesia, having a surgical procedure where neuromonitoing with somatosensory evoked potentials and motor evoked potentials neuromonitoring is requested by the surgical team
排除标准
- •Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit
研究组 & 干预措施
Fosaprepitant
Patients included in this study will be administered fosaprepitant 150 mg IV.
干预措施: Fosaprepitant 150 mg (Drug)
结局指标
主要结局
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Upper Extremity)
时间窗: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.
Motor Evoked Potentials Amplitude (Left Upper Extremity)
时间窗: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Neuromonitoring modality utilized during surgical procedures affecting motor component of central and peripheral nervous system. MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation \[TMS\]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles.
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Upper Extremity)
时间窗: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Left Lower Extremity)
时间窗: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.
Somatosensory Evoked Potentials (SEPs), Extremity Amplitude (Right Lower Extremity)
时间窗: Baseline (pre-dose) and 30, 60, and 90 minutes post-dose
Neuromonitoring modality utilized during surgical procedures potentially affecting sensory component of central and peripheral nervous system. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 4-channel EEG system at baseline (predose) and regularly after study drug administration.
次要结局
未报告次要终点
研究者
Mark Burbridge
Clinical Assistant Professor
Stanford University