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

ConditionTraumatic Brain Injuries
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Propofol

    Drug

    evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

  • Dexmedetomidine

    Drug

    evaluate intracranial pressure and serum Malondialdehyde (MDA) levels

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group P : Propofol will be initiated at a continuous infusion dose of 5-50 mcg/kg/min.Experimental treatment 1 intervention
Group B: Group D : Dexmedetomidine will be initiated at a continuous infusion dose of 0.2-0.7 mcg/kg/hoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
every 6 hours for 48 hours

Secondary outcomes

1

Serum Malondialdehyde (MDA) levels.

Time frame
At 0 hours and after 48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: