NCT06661980

Dexmedetomidine on Brain Injury Patients

Effect of Dexmedetomidine on Brain Injury Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Injuries

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Injectable Solution	Dexmedetomidine 200 mcg/ 2 mL IV.
OTHER	Placebo	Normal Saline 2ml IV.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2024-10-28
• Last updated: 2026-01-08

Locations

1 site across 1 country: Egypt