Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

NCT07678216 · tracked via the Priya Life Science Egypt tracker

Sponsor

Aswan University

Phase

Not applicable

Started

2026-07-01

Last updated

2026-07-01

Condition(s) studied

Moderate-to-Severe Traumatic Brain Injury

Investigational drug(s) / intervention(s)

propofol →midazolam →Dexmedetomidine →

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.

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD) — 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.

Trial sites (1)

Facility	City	Region	Status
Aswan University Hospital	Asyut	Asyut Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07678216 on ClinicalTrials.gov ↗ ← All trials in Egypt