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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

NCT04006054

Traumatic Brain Injury

UNKNOWN PHASE4

The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

NCT02078583

Delirium

UNKNOWN PHASE4

Dexmedetomidine in Patients After Intracranial Surgery

NCT01445639

Central Nervous System Diseases

COMPLETED PHASE4

Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects

NCT02269202

Healthy

COMPLETED PHASE1

A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

NCT01970072

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N1(traditional treatment group)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

N2(midazolam group)

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.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam

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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No