Dexmedetomidine on Brain Injury Patients

Last updated: January 6, 2026
Sponsor: Damanhour University
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

Dexmedetomidine Injectable Solution

Placebo

Clinical Study ID

NCT06661980
DXM in brain Injury
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 60 Patients with brain injury with age ranging from 18 to 70 years, there are nolimits to gender.

Exclusion

Exclusion Criteria:

  • Patients with significant liver impairment

  • Patients with known heart failure

  • Patients with hypotension

  • Patients with bradycardia

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Dexmedetomidine Injectable Solution
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
October 28, 2025

Study 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.

Connect with a study center

  • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

    Damanhūr, Elbehairah 31527
    Egypt

    Site Not Available

  • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

    Damanhūr 358449, Elbehairah 31527
    Egypt

    Site Not Available

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