A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury

Subei People's Hospital of Jiangsu Province

Status and phase: Unknown; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Drug: Placebo; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02071407

2014021801

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

N1(traditional treatment group)

Placebo Comparator group

Description:

Patients in group N1 are treated with basic therapeutic measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.

Treatment:

Drug: Placebo

N2(midazolam group)

Experimental group

Description:

Patients in group N2 was treated with intravenous infusion of midazolam on the basis of basic treatment measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.

Treatment:

Drug: Midazolam