A Phase 4 interventional study of Dexmedetomidine and Midazolam in Traumatic Brain Injury, sponsored by Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Xiangya Hospital of Central South University · Phase 4, Interventional, and Prevention
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 82 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days
Drug: Dexmedetomidine
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days
Drug: Midazolam
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
Also known as: DG
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Also known as: MG
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
Norepinephrine
Norepinephrine 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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Xiangya Hospital of Central South University