Dexmedetomidine on Brain Injury Patients

NCT06661980 | Completed

• 1 other identifier: DXM in brain Injury
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

• 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

• length of intensive care department stay (days)

  length of intensive care department stay.

  1 month

Secondary Outcomes (2)

• Neuron Specific Enolase (ng/ml)

  1 Week

• tau protein (ng/L)

  1 Week

Study Arms (2)

Dexmedetomidine Group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine Injectable Solution

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexmedetomidine Injectable Solution DRUG

Dexmedetomidine 200 mcg/ 2 mL IV.

Also known as: Dexmedetomidine

Dexmedetomidine Group

Placebo OTHER

Normal Saline 2ml IV.

Also known as: NS

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.

You may not qualify if:

• Patients with significant liver impairment
• Patients with known heart failure
• Patients with hypotension
• Patients with bradycardia

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

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

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 36204225 BACKGROUND

• 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.

  PMID: 26530364 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tarek M. Mostafa, Prof.

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 15, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)