NCT06993194 · NOT YET RECRUITING
Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury
This trial compares two drugs — haloperidol and dexmedetomidine — for controlling delirium and agitation in ICU patients who have suffered a traumatic brain injury and are on a ventilator. It measures things like delirium severity, agitation levels, days on the ventilator, and ICU length of stay. This is a small, 40-patient study — an early-stage comparison trial, not a phase that establishes proof of effectiveness.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-28