NCT06620393 · Phase 2 · NOT YET RECRUITING
Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients
This trial is testing whether dexmedetomidine, a mild sedative, can reduce dangerous agitation in ICU patients who have suffered a traumatic brain injury. The goal right now is mainly to see if a larger trial is even feasible to run across multiple hospitals. It is a Phase 2 trial, meaning it is an early-stage test of whether the approach works and is safe, not a proven or approved treatment.
You may qualify if
- Adults (≥18 years) admitted to ICU with a critically ill moderate or severe TBI patients. Severity of TBI will be determined with the first Glasgow Coma Score (GCS). TBI patients with polytrauma and patients undergoing neurosurgical interventions will be eligible.
- Undergoing mechanically ventilation (of any duration) at the time of assessment.
- Anticipated ICU stay of 48 hours or more.
You're excluded if
- Patients at very high risk of short-term mortality (e.g., GCS of 3 without sedation, or unreactive pupils, or declared brain-dead when assessed for eligibility and patients in whom there is a lack of commitment to ongoing life support
- Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)
- Patients with cognitive impairment as per family evaluation
- Pregnant or breastfeeding
- Patients currently receiving DEX or clonidine
- Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician
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 2024-10-01