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

Xiangya Hospital of Central South University82 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

DexmedetomidineDRUG

When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .

MidazolamDRUG

When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

Epinephrine

Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 48 hours after injury

Central Contacts

Xin Chen, Doctor

CONTACT

13517315332 21806497@qq.com

Data from ClinicalTrials.gov

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