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NOT YET RECRUITING
NCT07678216
NA

Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

Sponsor: Aswan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-07-01

Completion Date

2028-06-01

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Locations (1)

Aswan University Hospital

Asyut, Asyut Governorate, Egypt