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Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury (ICP-TBI)

24 juni 2026 bijgewerkt door: Mohamed Abdelhameed Sayed, Aswan University

Effect of Propofol, Midazolam, and Dexmedetomidine on Intracranial Pressure and Clinical Outcomes in Patients With Moderate-to-Severe Traumatic Brain Injury Undergoing Urgent Neurosurgical Intervention

The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.

The main questions it aims to answer are:

  • Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?
  • How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?

Participants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide. Prevention of secondary brain injury through optimal control of intracranial pressure (ICP) is a key component of intensive care management in patients with moderate-to-severe TBI. Sedative agents are routinely used to facilitate mechanical ventilation, reduce cerebral metabolic demand, and improve ICP control. However, uncertainty remains regarding the optimal sedative agent for this patient population.

Propofol, midazolam, and dexmedetomidine are among the most commonly used sedatives in neurocritical care. Each agent has distinct pharmacological characteristics that may influence intracranial pressure, hemodynamic stability, neurological assessment, and clinical outcomes. Despite widespread use, direct comparative evidence between these agents remains limited.

This prospective randomized clinical trial aims to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adult patients with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention. Intracranial pressure will be assessed noninvasively using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography during the first 24 hours of continuous sedation.

Participants will be randomly assigned to receive one of the three sedative regimens according to a standardized protocol targeting a Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Standard neurocritical care management and analgesia protocols will be applied to all study groups.

The study will evaluate the comparative effects of the three sedative agents on intracranial pressure control, sedation quality, hemodynamic stability, adverse events, secondary brain injury, and short-term clinical outcomes. The findings are expected to provide evidence to guide sedative selection in patients with moderate-to-severe traumatic brain injury, particularly in settings where invasive intracranial pressure monitoring is not routinely available.

Studietype

Ingrijpend

Inschrijving (Geschat)

210

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypte, 81528
        • Aswan university hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Age ≥18 years

    • Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12
    • Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury
    • Admitted to ICU and expected to require continuous sedation
    • Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg/kg/min norepinephrine equivalent)
    • Informed consent obtained from legally authorized representative

Exclusion Criteria:

  • The Relative refusal to participate in the research.
  • Known allergy or contraindication to propofol, midazolam, or dexmedetomidine
  • Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment
  • Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure
  • Severe renal dysfunction (eGFR <30 mL/min/1.73m² or requiring renal replacement therapy)
  • Pregnancy or breastfeeding
  • Hemodynamic instability requiring norepinephrine >0.1 mcg/kg/min or equivalent vasopressor support
  • Heart rate <50 bpm or second/third-degree AV block without pacemaker (relative contraindication for dexmedetomidine)
  • Clinical determination of brain death or expected survival <24 hours
  • Enrollment in another interventional trial
  • Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Propofol
Participants receive continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated to 1-4 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Geneesmiddel: propofol
Continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period.
Experimenteel: Midazolam
Participants receive continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated to 0.02-0.1 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Geneesmiddel: midazolam
Continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. An initial bolus dose of 0.05 mg/kg may be administered if rapid sedation is required.
Experimenteel: dexmedetomidine
Participants receive continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated to 0.2-0.7 μg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Geneesmiddel: Dexmedetomidine
Continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. No loading dose will be administered.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD)
Tijdsspanne: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation
Intracranial pressure control will be evaluated using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography. The primary outcome will be the mean ONSD over the 24-hour intervention period, analyzed as a continuous measure of intracranial pressure control.
Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Time at Target Sedation Level
Tijdsspanne: 24 hours after initiation of sedation
Percentage of assessment time during which patients maintained the target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. The Richmond Agitation-Sedation Scale ranges from +4 (combative) to -5 (unarousable). Higher scores indicate greater agitation, whereas lower scores indicate deeper sedation. The target sedation level for this study is RASS -3 to -4.
24 hours after initiation of sedation
Mean Richmond Agitation-Sedation Scale (RASS) Score
Tijdsspanne: 24 hours after initiation of sedation
Mean Richmond Agitation-Sedation Scale (RASS) score during the 24-hour intervention period. The RASS ranges from +4 (combative) to -5 (unarousable), with target sedation defined as -3 to -4.
24 hours after initiation of sedation
Need for Rescue Sedation
Tijdsspanne: 24 hours after initiation of sedation
Proportion of patients requiring rescue sedation due to failure to achieve target sedation despite maximum protocol dose.
24 hours after initiation of sedation
Time to Achieve Target Sedation
Tijdsspanne: 24 hours after initiation of sedation
Time from initiation of study sedative infusion until achievement of target Richmond Agitation-Sedation Scale (RASS) score (-3 to -4).The RASS ranges from +4 (combative) to -5 (unarousable)
24 hours after initiation of sedation
Incidence of Hypotension
Tijdsspanne: 24 hours after initiation of study sedation
Incidence of hypotension, defined as mean arterial pressure (MAP) <65 mmHg or cerebral perfusion pressure (CPP) <60 mmHg.
24 hours after initiation of study sedation
Vasopressor Requirements
Tijdsspanne: 24 hours after initiation of study sedation.
Vasopressor requirements assessed by the proportion of patients requiring vasopressor support.
24 hours after initiation of study sedation.
Incidence of Bradycardia.
Tijdsspanne: 24 hours after initiation of study sedation.
Percentage of participants who develop bradycardia, defined as a sustained heart rate <50 beats per minute (bpm).
24 hours after initiation of study sedation.
Percentage of Participants Who Developed Secondary Brain Injury ✅
Tijdsspanne: Baseline and 24 hours after initiation of study sedation.
Secondary brain injury will be assessed by the presence of new or progressive findings on brain computed tomography (CT) compared with baseline imaging, including new intracranial hemorrhage, progression of cerebral edema (defined as >25% increase in midline shift or worsening basal cistern effacement), new cerebral infarction, or transtentorial or uncal herniation. Brain CT scans will be reviewed by a blinded neuroradiologist.
Baseline and 24 hours after initiation of study sedation.
Duration of Mechanical Ventilation
Tijdsspanne: From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.
Duration of invasive mechanical ventilation, measured as the number of days from initiation of mechanical ventilation until successful liberation from ventilatory support.
From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.
Time to Neurological Awakening
Tijdsspanne: From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.
Time from discontinuation of study sedation to achievement of a Glasgow Coma Scale (GCS) motor score of ≥5. The Glasgow Coma Scale motor component ranges from 1 (no motor response) to 6 (obeys commands), with higher scores indicating better neurological function.
From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.
ICU Mortality
Tijdsspanne: From ICU admission until ICU discharge, assessed for up to 30 days.
Death from any cause during the ICU stay following urgent neurosurgical intervention for traumatic brain injury.
From ICU admission until ICU discharge, assessed for up to 30 days.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aswan University

Onderzoekers

  • Studie stoel: Ahmed Elsaied Aly, Ph.D., Sohag University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

20 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1230/3/26

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be shared because the study contains sensitive clinical data, and sharing could compromise participant confidentiality. Data are subject to institutional policies and ethics committee restrictions.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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