Brain InjuriesNCT06661980
Dexmedetomidine on Brain Injury Patients
A study testing Dexmedetomidine Injectable Solution in people with Brain Injuries, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Dexmedetomidine Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.
Who cannot join
- Patients with significant liver impairment
- Patients with known heart failure
- Patients with hypotension
- Patients with bradycardia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, 31527
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Brain Injuries
- Being tested
- Dexmedetomidine Injectable Solution, Placebo
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injectable SolutionDrug
Also called Dexmedetomidine
Dexmedetomidine 200 mcg/ 2 mL IV.
PlaceboOther
Also called NS
Normal Saline 2ml IV.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | 30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion). Receives: Drug: Dexmedetomidine Injectable Solution |
| Placebo Group | Placebo comparator | 30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
length of intensive care department stay (days)
length of intensive care department stay.
Measured: 1 month
Secondary outcomes (2)
Neuron Specific Enolase (ng/ml)
Biomarker (NSE)
Measured: 1 Week
tau protein (ng/L)
Biomarker
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Oct 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Tarek M. Mostafa, Prof., Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661980
- Sponsor's protocol ID
- DXM in brain Injury
- Status last verified
- May 2026
- First submitted
- 25 Oct 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36204225Isgro 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.
PubMed 26530364
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Brain Injury Patients
- ClinicalTrials.gov ID
- NCT06661980
- Acronym / sponsor ID
- DXM in brain Injury
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Dexmedetomidine Injectable Solution30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion). |
| Placebo Group | Placebo comparator | Other: Placebo30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.
Key exclusion criteria (4 listed)
- Patients with significant liver impairment
- Patients with known heart failure
- Patients with hypotension
- Patients with bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Injectable SolutionAlso: DexmedetomidineDexmedetomidine 200 mcg/ 2 mL IV. | Drug | Dexmedetomidine Group |
| PlaceboAlso: NSNormal Saline 2ml IV. | Other | Placebo Group |
Primary outcome
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.
length of intensive care department stay (days)
Time frame: 1 month
length of intensive care department stay.
2 secondary outcomes
Neuron Specific Enolase (ng/ml)
Time frame: 1 Week
tau protein (ng/L)
Time frame: 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 36204225Hu 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.
- Background: PubMed 26530364Isgro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M. Mostafa, Prof. study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Injectable Solution in people with Brain Injuries, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (number) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.