Clinical trial NCT04006054: Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
Official title: Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Traumatic Brain Injury
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epinephrine
timeFrame: At admission (baseline)
measure: Epinephrine
timeFrame: 24 hours after injury
measure: Epinephrine
timeFrame: 48 hours after injury
measure: Epinephrine
timeFrame: 72 hours after injury
measure: Norepinephrine
timeFrame: At admission (baseline)
measure: Norepinephrine
timeFrame: 24 hours after injury
measure: Norepinephrine
timeFrame: 48 hours after injury
measure: Norepinephrine
timeFrame: 72 hours after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
References: