Dexmedetomidine on Brain Injury Patients

Damanhour University

Status: Completed

Conditions: Brain Injuries

Treatments: Other: Placebo; Drug: Dexmedetomidine Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06661980

DXM in brain Injury

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Dexmedetomidine Group

Active Comparator group

Description:

30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion).

Treatment:

Drug: Dexmedetomidine Injectable Solution

Placebo Group

Placebo Comparator group

Description:

30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion).

Treatment:

Other: Placebo