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.
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.
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
Parallel
Dexmedetomidine
DrugDEX 4 mcg/100 ml at a starting dose of 0.6 mcg/kg/hour and increased by 0.2 mcg/kg/hour every 30 minutes up to final dose of 1.4 mcg/kg/hour.
Placebo
DrugNaCl 0.9% 100ml
Protocol adherence
Proportion of hours the drug was administered
Trial recruitment
Recruitment rate and randomization/activation process (consent rate, proportion of recruited patients who receive the study drug)
Blinding maintenance
Proportion of intensivists and nurses predicting study group assignment at the end of the study intervention and proportion of patients receiving propofol
Proportion of data collection completed
Data collection completeness for agitation-related events, posttraumatic amnesia and cognitive recovery
ICU-days free of agitation or coma within 14 days following randomization
Number of ICU-days without agitation or coma within 14 days following randomization
Agitation-related event during the ICU stay
Accidental device removal, self-extubation following randomization in the ICU
Proportion of patients and the number of days exposed to antipsychotics, benzodiazepines and physical restraints
Exposure to antipsychotics, benzodiazepines and physical restraints after randomization during ICU stay
Time to mechanical ventilation liberation (extubation), time to ICU and hospital discharge
Time to mechanical ventilation liberation (extubation), time to ICU and hospital discharge
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead sponsor
Canadian Critical Care Trials Group
Collaborator
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