Effect of Ketamine on Intraoperative Motor Evoked Potentials
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of ketamine on intraoperative motor evoked potentials in adult patients undergoing thoracolumbar spinal fusions. Participants will undergo a standard anesthetic. In addition to the standard anesthetic, the patients will be administered increasing doses of ketamine with motor-evoked potentials being measured at each dose, to assess any impacts.
详细描述
Spinal surgeries continue to increase in frequency and complexity. An important safety protocol is the use of intraoperative motor evoked potentials (MEP) to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury. Transcranial electric motor evoked potentials stimulate the motor cortex and produce a myogenic response. This modality can assess the function of all pathways including the motor cortex, the lateral corticospinal tracts, the function of the alpha motor neurons, and peripheral nerves.
Various anesthetic agents can impact the critical parameters of MEPs. Inhaled volatile anesthetics and nitrous oxide are highly suppressive in a dose-dependent manner decreasing the amplitude of the myogenic response and prolonging the latency. Propofol is also suppressive of MEPs, although high quality data can still be obtained at clinically relevant doses for anesthesia. For this reason, most anesthesiologists will use propofol as the backbone of any anesthetic that involves neurophysiologic monitoring.
Because spine surgeries are exceptionally painful, anesthesiologists will often incorporate adjuncts that can decrease pain and postoperative opioid usage. The effect of these adjuncts on intraoperative evoked potentials is incompletely described and important work remains to detail these effects.
Ketamine, a phencyclidine derivative that is an NMDA receptor antagonist, is a widely used adjunct anesthetic due to its analgesic and hypnotic properties during spine surgeries. Ketamine has shown significant opioid-sparing and analgesic benefits when used in patients undergoing spine surgery.
Intraoperative neuromonitoring (IONM), including motor evoked potentials (MEP), are increasingly used during spinal surgeries to help identify potentially reversible injury to neural structures.
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
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years of age) undergoing posterior spinal fusions.
排除标准
- •Sensitivity or allergy to ketamine.
- •Schizophrenia or other psychotic conditions
- •Uncontrolled hypertension with systolic blood pressure greater than 180 mmHg
- •Myocardial Infarction
- •Large vascular aneurysms
- •Patients on ketamine as outpatient therapy.
研究组 & 干预措施
Ketamine
All subjects will be in a single arm. Patients will serve as their own control.
Patients will receive general anesthesia in the usual fashion for the indicated procedures. This anesthetic will be standardized between patients. All patients participating in the study will have neuromonitoring as part of their spine surgery as standard care. Baseline motor-evoked potential data will then be collected. Then study drug Ketamine will be administered as following:
- Step 1: 0.1 mg/kg bolus over 30 sec followed by infusion of 3mcg/kg/min (0.18 mg/kg/hr)
- Step 2: 0.3 mg/kg bolus over 30 sec followed by infusion of 15mcg/kg/min (0.9mg/kg/hr)
- Step 3: 0.85 mg/kg bolus over 30 sec followed by infusion at 50mcg/kg/min (3mg/kg/hr)
Motor Evoked Potentials will be collected for 5 times at minutes 2, 4, 6, 8, 10 after drug step.
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration
时间窗: 30 minutes
MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.
Change in motor evoked potentials (MEP) facilitation in response to intraoperative ketamine administration
时间窗: 30 minutes
MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.
Change in supramaximal motor evoked potentials (MEP) in response to intraoperative ketamine administration
时间窗: 30 minutes
MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.
次要结局
- Ketamine Plasma Level(30 minutes)
