Clinical trial NCT06661980: Dexmedetomidine on Brain Injury Patients
Official title: Effect of Dexmedetomidine on Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glasgow Coma Scale (number)
timeFrame: 1 week
measure: length of intensive care department stay (days)
timeFrame: 1 month
Secondary outcomes:
measure: Neuron Specific Enolase (ug/dl)
timeFrame: 1 Week
measure: tau protein (ug/dl)
timeFrame: 1 Week
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
state: Elbehairah
Study officials:
affiliation: Tanta University
name: Tarek M. Mostafa, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.