Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
NCT ID: NCT04006054
Last Updated: 2019-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
82 participants
INTERVENTIONAL
2019-06-06
2021-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Dexmedetomidine treatment group
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days
Dexmedetomidine
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
Midazolam treatment group
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days
Midazolam
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Interventions
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Dexmedetomidine
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
Midazolam
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate or severe traumatic brain injury
3. GCS≤12
4. Diagnosed by CT
5. No catecholamines (such as dopamine, adrenaline, norepinephrine) have been used before admission
6. Have a clear history of head trauma
7. Non-open traumatic brain injury
Exclusion Criteria
2. Severe renal dysfunction (serum creatinine \> 445 mmol / L or blood urea nitrogen \> 20 mmol / L)
3. Hemodynamic instability when entering the ICU (heart rate \<50 beats / min or hypotension, SBP \<90mmHg or MAP \<65mmHg)
4. Deaths within 72 hours after entering the ICU
5. Severe multiple injuries (ISS≥25 points)
6. Have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.)
7. Allergic to dexmedetomidine or midazolam
8. Observed with the results of disease interference test (such as pheochromocytoma, etc.)
9. In pregnancy or lactation
10. Receiving hypothermia treatment
11. Are participating in other drug research or clinical trials
18 Years
70 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Locations
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Xiangya Hospital Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019040111
Identifier Type: -
Identifier Source: org_study_id
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