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Traumatic Brain InjuriesPhase 4NCT07807579

Impact of Dexmedetomidine Versus Propofol on Intracranial Pressure in Adult Traumatic Brain Injury Patients: Randomized Controlled Double-Blind Trial

A Phase 4 study testing Propofol and Dexmedetomidine in people with Traumatic Brain Injuries, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To investigate whether dexmedetomidine or propofol is more effective in controlling intracranial pressure (ICP) (assessed via optic nerve sheath diameter "ONSD" as a primary outcome) and which is more effective in suppressing lipid peroxidation (measured via malondialdehyde "MDA" as a secondary outcome). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Traumatic Brain Injuries
What is being tested?
Propofol and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 1 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18 and 65 years.
  • Both genders.
  • Moderate traumatic brain injury with Glasgow coma scale scores between 8 and 12 on admission, with no need for surgical operations.
  • Requiring continuous sedation for more than 24 hours.

Who cannot join

  • History of severe hepatic or renal failure.
  • Known hypersensitivity to propofol or dexmedetomidine.
  • Pre-existing severe bradycardia (heart rate less than 50 bpm) or advanced heart block.
  • Confirmed brain death or moribund patients.
  • Pregnancy or lactation.
  • Preexisting neurological disease affecting GCS interpretation.
Show all 9Show fewer
  • General anesthesia 24 hours prior to or planned after the start of study drug infusion.
  • Serious central nervous system pathology (acute stroke, severe dementia, uncontrolled seizures).
  • Any patients with ocular trauma, orbital fractures, glaucoma, or history of optic nerve disease.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

To investigate whether dexmedetomidine or propofol is more effective in controlling intracranial pressure (ICP) (assessed via optic nerve sheath diameter "ONSD" as a primary outcome) and which is more effective in suppressing lipid peroxidation (measured via malondialdehyde "MDA" as a secondary outcome). This double-blind randomized controlled trial aims to bridge this research gap by evaluating the biochemical neuroprotective efficacy alongside the clinical outcomes of both agents in TBI patients.

Read the detailed description

Traumatic brain injury (TBI) remains a leading cause of mortality and permanent disability worldwide, posing a major challenge in neurocritical care. The primary injury occurs at the moment of impact, resulting in immediate mechanical tissue disruption. However, the subsequent secondary brain injury develops over hours to days, driven by complex cascades of neuroinflammation, excitotoxicity, mitochondrial dysfunction, and severe oxidative stress (Werner and Engelhard, 2007).

Oxidative stress is characterized by an imbalance between the production of reactive oxygen species (ROS) and the body's antioxidant defense mechanisms. The brain is particularly vulnerable to oxidative damage due to its high oxygen consumption, high lipid content (especially polyunsaturated fatty acids), and relatively low levels of antioxidant enzymes (Hall et al., 2010). During secondary injury, massive ROS production leads to lipid peroxidation, a process that degrades cell membranes and disrupts cellular integrity. Malondialdehyde (MDA) is a well-established, highly stable end-product of lipid peroxidation. Elevated systemic and cerebrospinal fluid levels of MDA serve as a reliable and sensitive biomarker for quantifying the severity of oxidative stress and predicting neurological outcomes in TBI patients (Lorente et al., 2015).

Sedation is a cornerstone in the management of mechanically ventilated TBI patients in the Intensive Care Unit (ICU). It is essential to decrease metabolic demands, facilitate mechanical ventilation, prevent spikes in intracranial pressure (ICP), and control agitation (Roberts et al., 2011).

Dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, has emerged as a promising alternative in neurointensive care. It provides "conscious sedation" without causing significant respiratory depression, allowing for easier neurological evaluation. Beyond its sedative properties, evolving preclinical and clinical evidence suggests that dexmedetomidine exerts potent neuroprotective effects (Arain and Ebert, 2002). These effects are hypothesized to be mediated through the reduction of central sympathetic outflow, attenuation of neuroinflammation, and direct modulation of oxidative stress pathways, leading to a reduction in lipid peroxidation biomarkers like MDA (Wang et al., 2019).

Propofol is a lipid-soluble anesthetic, used intravenously in the clinics for sedation in the ICU and for general anesthesia. The antioxidant properties of propofol have been attributed to the similarity of its chemical structure to known antioxidants such as butylhydroxytoluene and α-tocopherol. It has been reported that the antioxidant properties of propofol are not only inhibiting lipid peroxidation, but also scavenging the ROS that have been formed (Demiryürek et al., 1998).

Keywords
effect of Propofol vs Dexmedetomidine on ICP
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

  • DexmedetomidineDrug

    evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

Study groups in NCT07807579
Study groupRoleWhat they receive
Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min.Experimental40 patients will be received Propfol at a continuous infusion dose of 5-50 mcg/kg/min.
Receives: Drug: Propofol
Group D : Dexmedetomidine will be initiated at a continuous infusion dose of 0.2-0.7 mcg/kg/hoExperimental40 patients will be received Dexmedetomidine at a continuous infusion dose of 0.2-0.7 mcg/kg/hour without a loading dose to avoid hemodynamic instability.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-invasive intracranial pressure monitoring by optic nerve sheath diameter measurement.

    Measured: every 6 hours for 48 hours

Secondary outcomes (1)
  1. Serum Malondialdehyde (MDA) levels.

    Measured: At 0 hours and after 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807579
Sponsor's protocol ID
propfol vs dexmed. on ICP
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Dexmedetomidine in people with Traumatic Brain Injuries, run by Assiut University.

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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hassan Khaled Ahmed (01067319365, hassssan.khaled2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-invasive intracranial pressure monitoring by optic nerve sheath diameter measurement. (time frame: every 6 hours for 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Sep 2026.

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