Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

About this trial

Agitation is a frequent complication following traumatic braing injury in patients admitted to the intensive care unit. This agitation frequently results in the liberal use of rescue drugs such as antipsychotics, sedatives and opiates, which in turn may delay rehabilitation, liberation from mechanical ventilation and emergence from posttraumatic amnesia. Dexmedetomidine may be a better agent given it's light sedative properties. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Placebo

Treatment groups

72 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators