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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Dexmedetomidine 200 mcg/ 2 mL IV.
Normal Saline 2ml IV.
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, Egypt
Glasgow Coma Scale (number)
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.
Time frame: 1 week
length of intensive care department stay (days)
length of intensive care department stay.
Time frame: 1 month
Neuron Specific Enolase (ng/ml)
Biomarker (NSE)
Time frame: 1 Week
tau protein (ng/L)
Biomarker
Time frame: 1 Week
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