Dexmedetomidine on Brain Injury Patients

Effect of Dexmedetomidine on Brain Injury Patients

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Drug: Dexmedetomidine Injectable Solution; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elbehairah
    • Damanhūr, Elbehairah, Egypt, 31527
      • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine Group; 30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion).	Drug: Dexmedetomidine Injectable Solution; Dexmedetomidine 200 mcg/ 2 mL IV.; Other Names: Dexmedetomidine
Placebo Comparator: Placebo Group; 30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion).	Other: Placebo; Normal Saline 2ml IV.; Other Names: NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of intensive care department stay (days)	length of intensive care department stay.	1 month
Glasgow Coma Scale (number)	GCS The highest possible 15, and the lowest is 3. A score of 15 means fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means a coma. The lower the score, the deeper the coma is.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuron Specific Enolase (ng/ml)	Biomarker (NSE)	1 Week
tau protein (ng/L)	Biomarker	1 Week

Collaborators and Investigators

• Sponsor: Damanhour University
• Collaborators: Tanta University
• Investigators: Study Chair: Tarek M. Mostafa, Prof., Tanta University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: DXM in brain Injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No