Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Benha University

Conditions:

Traumatic Brain Injury

Delirium

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Traumatic brain injury is a serious and common medical condition that often requires admission to the intensive care unit and the use of mechanical ventilation. One of the most frequent and challengin...

Eligibility Criteria

Inclusion

  • Adults aged 18 years or older
  • Confirmed diagnosis of traumatic brain injury
  • Admission to the intensive care unit
  • Currently receiving mechanical ventilation
  • Richmond Agitation-Sedation Scale score between -5 and +4
  • At least 48 hours have passed since ICU admission

Exclusion

  • Pre-existing neurological or psychiatric disorders (e.g., schizophrenia, bipolar disorder)
  • Known allergy or contraindication to haloperidol or dexmedetomidine
  • Significant hepatic or renal dysfunction
  • Pregnant or breastfeeding women
  • History of prolonged QT interval or other cardiac arrhythmias
  • Use of long-term antipsychotic or sedative medications before ICU admission

Key Trial Info

Start Date :

June 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 15 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06993194

Start Date

June 15 2025

End Date

June 15 2026

Last Update

May 28 2025

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