NCT07807579

Brief 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). 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
15mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jan 2028

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 2, 2026

Last Update Submit

September 8, 2026

Conditions

Traumatic Brain Injuries

Keywords

effect of Propofol vs Dexmedetomidine on ICP

Outcome Measures

Primary Outcomes (1)

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

    every 6 hours for 48 hours

Secondary Outcomes (1)

  • Serum Malondialdehyde (MDA) levels.

    At 0 hours and after 48 hours

Study Arms (2)

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.

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.

Drug: Dexmedetomidine

Interventions

PropofolDRUG

evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min.
DexmedetomidineDRUG

evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

Group D : Dexmedetomidine will be initiated at a continuous infusion dose of 0.2-0.7 mcg/kg/ho

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

PropofolDexmedetomidine

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Hassan Khaled Ahmed

CONTACT

01067319365hassssan.khaled2013@gmail.com

Mahmoud Adel Ali

CONTACT

01004391577dr_mahmoudfaisal@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Invetigator

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09