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.
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.
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- 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).
- Conditions
- Traumatic Brain Injuries
- Being tested
- Propofol, Dexmedetomidine
- 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 group | Role | What they receive |
|---|---|---|
| Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min. | Experimental | 40 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/ho | Experimental | 40 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.
Non-invasive intracranial pressure monitoring by optic nerve sheath diameter measurement.
Measured: every 6 hours for 48 hours
Secondary outcomes (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.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Khaled ahmed gomaa, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine Versus Propofol on Intracranial Pressure in Adult Traumatic Brain Injury Patients: Randomized Controlled Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07807579
- Acronym / sponsor ID
- propfol vs dexmed. on ICP
- Conditions
- Traumatic Brain Injuries
- Keywords
- effect of Propofol vs Dexmedetomidine on ICP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 Sep 2026 (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.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min. | Experimental | Drug: Propofol40 patients will be received Propfol at a continuous infusion dose of 5-50 mcg/kg/min. |
| Group D : Dexmedetomidine will be initiated at a continuous infusion dose of 0.2-0.7 mcg/kg/ho | Experimental | Drug: Dexmedetomidine40 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Propofolevaluate intracranial pressure and serum Malondialdehyde (MDA) levels | Drug | Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min. |
| Dexmedetomidineevaluate intracranial pressure and serum Malondialdehyde (MDA) levels | Drug | Group D : Dexmedetomidine will be initiated at a continuous infusion dose of 0.2-0.7 mcg/kg/ho |
Primary outcome
Non-invasive intracranial pressure monitoring by optic nerve sheath diameter measurement.
Time frame: every 6 hours for 48 hours
1 secondary outcome
Serum Malondialdehyde (MDA) levels.
Time frame: At 0 hours and after 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
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.