Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Epinephrine
研究概览
简要总结
The aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent PSH attacks and to achieve neuroprotection.
详细描述
Paroxysmal sympathetic hyperactivity (PSH) is a syndrome typically recognized in patients suffering from traumatic brain injury, characterized by paroxysmal increases in sympathetic activity such as elevated heart rate, increased blood pressure and respiratory rate, high temperature, excessive sweating and abnormal motor (posturing) activity.
This prospective study will include patients with traumatic brain injury,who will be divided into two groups, evaluated by the Paroxysmal Sympathetic Hyperactivity-Assessment Measure (PSH-AM). Patients will also be evaluated with head CT.
The aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent PSH attacks and to achieve neuroprotection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years
- •Moderate or severe traumatic brain injury
- •Diagnosed by CT
- •No catecholamines (such as dopamine, adrenaline, norepinephrine) have been used before admission
- •Have a clear history of head trauma
- •Non-open traumatic brain injury
排除标准
- •Severe liver dysfunction (Child-Pugh B or C)
- •Severe renal dysfunction (serum creatinine > 445 mmol / L or blood urea nitrogen > 20 mmol / L)
- •Hemodynamic instability when entering the ICU (heart rate <50 beats / min or hypotension, SBP <90mmHg or MAP <65mmHg)
- •Deaths within 72 hours after entering the ICU
- •Severe multiple injuries (ISS≥25 points)
- •Have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.)
- •Allergic to dexmedetomidine or midazolam
- •Observed with the results of disease interference test (such as pheochromocytoma, etc.)
- •In pregnancy or lactation
- •Receiving hypothermia treatment
- •Are participating in other drug research or clinical trials
研究组 & 干预措施
Dexmedetomidine treatment group
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
干预措施: Dexmedetomidine (Drug)
Midazolam treatment group
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
干预措施: Midazolam (Drug)
结局指标
主要结局
Epinephrine
时间窗: 72 hours after injury
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine
时间窗: 72 hours after injury
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
次要结局
未报告次要终点