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OpenTrials
Completed

NCT Number: NCT06661980

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Damanhūr, Elbehairah, 31527, Egypt

About this study

  • Approval will be obtained from the Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
  • All participants must agree to take part in this clinical study and provide informed consent.
  • The required sample size will be calculated.
  • 60 Patients with brain injury will be enrolled from the intensive care department, Damanhour medical national institute.
  • Serum samples will be collected for measuring the biomarkers.
  • 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.
  • All patients will be followed up during their stay in the intensive care department.
  • During their stay in the intensive care department, step 5 will be repeated.
  • Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  • 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.
  • Results, discussion, conclusion, and recommendations will be given.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injectable Solution

Drug

Dexmedetomidine 200 mcg/ 2 mL IV.

Other names: Dexmedetomidine

Placebo

Other

Normal Saline 2ml IV.

Other names: NS

Primary outcomes

  1. Glasgow Coma Scale (number)

    Time frame: 1 week

    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.

  2. length of intensive care department stay (days)

    Time frame: 1 month

    length of intensive care department stay.

Secondary outcomes

  1. Neuron Specific Enolase (ng/ml)

    Time frame: 1 Week

    Biomarker (NSE)

  2. tau protein (ng/L)

    Time frame: 1 Week

    Biomarker

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

Effect of Dexmedetomidine on Brain Injury Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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