Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

June 15, 2026

Study Completion Date

June 15, 2026

Conditions
Traumatic Brain InjuryDeliriumAgitation
Interventions
DRUG

Haloperidol

Haloperidol will be administered intravenously at a dose of 2.5 milligrams every eight hours over ten minutes. Treatment will begin 48 hours after admission to the intensive care unit and will continue for up to seven days or until delirium and agitation resolve. The need for additional sedation will be addressed with intravenous midazolam and fentanyl as required. The patient's clinical status will be monitored using standardized assessments including the Confusion Assessment Method for the Intensive Care Unit and the Richmond Agitation-Sedation Scale.

DRUG

Dexmedetomidine

Dexmedetomidine will be administered by continuous intravenous infusion at a dose of 0.5 micrograms per kilogram. Treatment will begin 48 hours after admission to the intensive care unit and will be repeated every other day for up to seven days or until delirium and agitation resolve. Rescue sedation may be provided with intravenous midazolam and fentanyl as clinically indicated. Delirium and agitation will be assessed regularly using validated tools such as the Confusion Assessment Method for the Intensive Care Unit and the Richmond Agitation-Sedation Scale.

All Listed Sponsors
lead

Benha University

OTHER

NCT06993194 - Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury | Biotech Hunter | Biotech Hunter