Traumatic Brain Injury
Conditions
Brief summary
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
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.
Interventions
DRUGDexmedetomidine
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
DRUGMidazolam
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-70 years 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
1. Severe liver dysfunction (Child-Pugh B or C) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epinephrine | At admission (baseline) | Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. |
| Norepinephrine | At admission (baseline) | Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly. |
Countries
China
Contacts
Primary ContactXin Chen, Doctor
Outcome results
None listed