A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Lactate/Pyruvate (L/P)Ratio
研究概览
简要总结
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
详细描述
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
- •Must require (be on) mechanical ventilation
- •must require (have in place) intracranial pressure (ICP) monitoring
- •must require (be receiving) continuous IV sedation
排除标准
- •Bleeding diathesis
- •Glasgow Coma Scale (GCS) < 5 with fixed pupils
- •elevated ICP that requires deep sedation
- •pulmonary instability
- •Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
- •status epilepticus
- •current neuromuscular blockade
研究组 & 干预措施
Precedex-Propofol
Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
干预措施: Dexmedetomidine (Drug)
Precedex-Propofol
Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
干预措施: Propofol (Drug)
Propofol- Precedex
Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
干预措施: Dexmedetomidine (Drug)
Propofol- Precedex
Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
干预措施: Propofol (Drug)
结局指标
主要结局
Lactate/Pyruvate (L/P)Ratio
时间窗: 1 hour
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
次要结局
未报告次要终点
研究者
Carmelo Graffagnino
Professor
Duke University