Brain Injuries
Conditions
Brief summary
The aim of the study is to check whether dexmedetomidine has neuroprotective properties in brain injury patients. The enrolled 60 patients will be divided into two groups; Group 1(n=30): are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.
Detailed description
1. Approval will be obtained from the Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2. All participants must agree to take part in this clinical study and provide informed consent. 3. The required sample size will be calculated. 4. 60 Patients with brain injury will be enrolled from the intensive care department, Damanhour medical national institute. 5. Serum samples will be collected for measuring the biomarkers. 6. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group. 7. All patients will be followed up during their stay in the intensive care department. 8. During their stay in the intensive care department, step 5 will be repeated. 9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 10. Measuring outcomes: the primary outcome is measuring the neuroprotection provided by dexmedetomidine reflected by change in patients' symptoms, while secondary outcome is the change in the level of biomarkers from baseline to post-treatment. 11. Results, discussion, conclusion, and recommendations will be given.
Interventions
Dexmedetomidine 200 mcg/ 2 mL IV.
OTHERPlacebo
Normal Saline 2ml IV.
Sponsors
Tanta University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 60 Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.
Exclusion criteria
* Patients with significant liver impairment * Patients with known heart failure * Patients with hypotension * Patients with bradycardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Coma Scale (number) | 1 week | GCS The highest possible 15, and the lowest is 3. A score of 15 means fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means a coma. The lower the score, the deeper the coma is. |
| length of intensive care department stay (days) | 1 month | length of intensive care department stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuron Specific Enolase (ng/ml) | 1 Week | Biomarker (NSE) |
| tau protein (ng/L) | 1 Week | Biomarker |
Countries
Egypt
Outcome results
None listed