Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, sedation, midazolam
Brief summary
To explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.
Interventions
DRUGMidazolam
For patients allocated into group N2, 2 mg midazolam will be injected intravenously, and then it will be given at 0.05-0.1 mg/(kg·h) by intravenous infusion. If a surgery is needed, infusion of midazolam will begin 3 hours after the operation and continue for at least 72 hours. During the sedation with midazolam, BIS should be kept at 60 to 80. Morphine can be used to supply adequate analgesia.
DRUGPlacebo
Sponsors
Subei People's Hospital of Jiangsu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 or older; * Hospitalized in ICU within 6 hours after the injury or after the operation; * Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury; * Informed consent is obtained.
Exclusion criteria
* Aged less than 18; * Death is expected in 24 hours; * History of neurological disease or history of drug abuse which may affect the outcome of the study; * Failed to obtain Informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral metabolic parameters | from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2 | N1 group: blood samples will be collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission N2 group: blood samples will be collected before the use of midazolam, 24 h, 48 h and 72 h after the use Blood sample will be collected every time from the radial artery and the jugular bulb separately. The blood sample will be used for blood gas analysis Detail parameters by blood test: levels of lactic acid, oxygen saturation(SaO2), partial pressure of oxygen(Pa02), jugular bulb venous oxygen saturation(SjvO2), jugular bulb oxygen partial pressure(PjvO2), hemoglobin(Hb) Calculated parameters: arterial oxygen content(Ca02), jugular venous oxygen saturation (SjvO2), arterial venous oxygen content difference(Da-jvO2), cerebral extraction of oxygen(CERO2), Lactate differences between jugular and arterial blood(AVDL) and Cerebral lactate acid production(CLP) |
| Parameters of intracranial inflammatory response | from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2 | N1: blood samples and cerebrospinal fluid are collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission N2: blood samples and cerebrospinal fluid are collected before the use of midazolam, 24 h, 48 h and 72 h after the use every time, 3 ml blood sample will be collected from the jugular bulb and 2 ml cerebrospinal fluid will be collected at the corresponding time The blood sample will be anticoagulated by EDTA and then it will be centrifuged at 3000 r/min for 10 minutes within 30 minutes from the collection. The supernatant liquid will be stored in the freezer at -70℃. The cerebrospinal fluid centrifuged at 3000 r/min for 10 minutes, and then the supernatant liquid will be stored in the freezer at -80℃. Detail parameters: sFkn and IL-6 levels of the blood sample and CSF will be tested 2 times by ELISA and then take the average. |
Secondary
| Measure | Time frame |
|---|---|
| Ramsay score | from the use of midazolam to 72 h after the use for group N2 |
| seizure | from the admission to ICU to 72 h after the admission |
| one-week mortality | from the admission to ICU to one week after the admission |
Countries
China
Contacts
Primary ContactRuiqiang Zheng, Doctor
Outcome results
None listed