Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70 years Moderate or severe traumatic brain injury GCS≤12 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine treatment group<br>Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days | Drug: Dexmedetomidine<br>* When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .<br>* Other names: DG;|
| Active Comparator: Midazolam treatment group<br>Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days | Drug: Midazolam<br>* When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .<br>* Other names: MG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epinephrine | Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | At admission (baseline) | 
| Epinephrine | Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 24 hours after injury | 
| Epinephrine | Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 48 hours after injury | 
| Epinephrine | Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 72 hours after injury | 
| Norepinephrine | Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | At admission (baseline) | 
| Norepinephrine | Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 24 hours after injury | 
| Norepinephrine | Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 48 hours after injury | 
| Norepinephrine | Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. | 72 hours after injury |