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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Subei People's Hospital of Jiangsu Province
• Treatments: Midazolam

Criteria

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.