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Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

ConditionModerate-to-Severe Traumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAswan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • propofol

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: PropofolExperimental treatment 1 intervention
Group B: MidazolamExperimental treatment 1 intervention
Group C: dexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation

Secondary outcomes

1

Proportion of Time at Target Sedation Level

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.

Time frame
24 hours after initiation of sedation
2

Mean Richmond Agitation-Sedation Scale (RASS) Score

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.

Time frame
24 hours after initiation of sedation
3

Need for Rescue Sedation

Proportion of patients requiring rescue sedation due to failure to achieve target sedation despite maximum protocol dose.

Time frame
24 hours after initiation of sedation
4

Time to Achieve Target 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)

Time frame
24 hours after initiation of sedation

Other outcomes

Sponsors and contacts

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

Aswan University

Lead sponsor

Source ClinicalTrials.gov

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