The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Brain Oxygen
研究概览
简要总结
The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •ASA I-III.
- •Scheduled for DBS.
排除标准
- •History of dystonia.
- •Severe heart failure with ejection fraction less than 30%.
- •History of obstructive sleep apnea.
- •History of renal failure with creatinine level > 2 mg/dl.
- •Allergies to α-2 agonists and propofol.
- •Current use of α-2 agonist medications such as clonidine.
研究组 & 干预措施
propofol
Subjects will be sedated with propofol.
干预措施: propofol (Drug)
dexmedetomidine
Subjects will be sedated with dexmedetomidine.
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Brain Oxygen
时间窗: during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods
Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.
Cerebral Blood Flow
时间窗: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.
Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.
次要结局
- Number of Apneic Episodes.(during DBS surgery)
- Cerebral Perfusion Pressure(at the first peak during DBS surgery)
- Cerebral Blood Flow(after procedure, in post anesthesia care unit (PACU))
- Pulsatility Index(at the first peak during DBS surgery)
- Number of Hypertensive Episodes(During DBS surgery)
- Alertness/Sedation(at the first peak during DBS surgery)
研究者
Ehab Farag
Principal Investigator
The Cleveland Clinic