Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-10-15
2025-10-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dexmedetomidine Group
30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion).
Dexmedetomidine Injectable Solution
Dexmedetomidine 200 mcg/ 2 mL IV.
Placebo Group
30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion).
Placebo
Normal Saline 2ml IV.
Interventions
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Dexmedetomidine Injectable Solution
Dexmedetomidine 200 mcg/ 2 mL IV.
Placebo
Normal Saline 2ml IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with known heart failure
* Patients with hypotension
* Patients with bradycardia
18 Years
70 Years
ALL
No
Sponsors
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Tanta University
OTHER
Damanhour University
OTHER
Responsible Party
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Rehab Werida
Associate Professor
Principal Investigators
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Tarek M. Mostafa, Prof.
Role: STUDY_CHAIR
Tanta University
Locations
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Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, Egypt
Countries
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References
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Hu Y, Zhou H, Zhang H, Sui Y, Zhang Z, Zou Y, Li K, Zhao Y, Xie J, Zhang L. The neuroprotective effect of dexmedetomidine and its mechanism. Front Pharmacol. 2022 Sep 20;13:965661. doi: 10.3389/fphar.2022.965661. eCollection 2022.
Isgro MA, Bottoni P, Scatena R. Neuron-Specific Enolase as a Biomarker: Biochemical and Clinical Aspects. Adv Exp Med Biol. 2015;867:125-43. doi: 10.1007/978-94-017-7215-0_9.
Other Identifiers
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DXM in brain Injury
Identifier Type: -
Identifier Source: org_study_id
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