A Phase 2/3 interventional study of Dexmedetomidine and Placebo in Traumatic Brain Injury and Agitation,Psychomotor, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Phase 2/3, Interventional, and Treatment
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.
Following a traumatic brain injury, agitation is reported in 53-57% of patients in the intensive care unit. As it is associated with accidental removal of catheters, tubes and dressings as well as self-extubation, agitation poses a threat to patient safety. In addition, agitation can be accompanied by aggressive behaviors that pose a threat to clinician safety. 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 is a highly selective alpha-2 adrenergic receptor agonist used for sedation and also has co-analgesic and withdrawal syndrome alleviating properties. Unlike other sedatives, patients remain easily roused when under dexmedetomidine, facilitating contact and removal from mechanical ventilation. In addition, dexmedetomidine does not induce respiratory depression in critically ill patients. The addition of dexmedetomidine may have the potential to reduce the incidence agitation while reducing the use of agitation rescue drugs such as antipsychotics, the use of physical restraints, as well as the time to cessation of mechanical ventilation and consequently, reduce the time to emergence for post-traumatic amnesia. Duration of posttraumatic amnesia is an important outcome as it is a predictor of cognitive and functional outcomes as well as community integration, psychosocial functioning and employment. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU. To evaluate the feasibility of conducting a large trial and to refine study procedures, a multicenter randomized double-blind placebo-controlled pilot study comparing dexmedetomidine to placebo will be conducted. The feasibility outcomes will include protocol adherence, trial recruitment and time-in-motion evaluation for study procedures. Clinical outcomes will include agitation, exposure to antipsychotics, time to emergence from post-traumatic amnesia, physical restraint use, ventilator days, and time to ICU and hospital discharge as well as ICU and hospital mortality.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 72 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 31 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DEX (4 mcg/100 ml supplied by Juno Pharmaceuticals) will be initiated 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.
Drug: Dexmedetomidine
Matching placebo (NS 0.9% 100ml)
Drug: Placebo
DEX 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.
Also known as: Precedex
NaCl 0.9% 100ml
Protocol adherence
Proportion of hours the drug was administered
Time frame: Through study completion, an average of 2 years
Trial recruitment
Recruitment rate and randomization/activation process (consent rate, proportion of recruited patients who receive the study drug)
Time frame: Through study completion, an average of 2 years
Blinding maintenance
Proportion of intensivists and nurses predicting study group assignment at the end of the study intervention and proportion of patients receiving propofol
Time frame: Through study completion, an average of 2 years
Proportion of data collection completed
Data collection completeness for agitation-related events, posttraumatic amnesia and cognitive recovery
Time frame: Through study completion, an average of 2 years
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
Time frame: During ICU stay up to 14 days
Agitation-related event during the ICU stay
Accidental device removal, self-extubation following randomization in the ICU
Time frame: Through study completion, an average of 2 years
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 frame: Through study completion, an average of 2 years
Time to mechanical ventilation liberation (extubation), time to ICU and hospital discharge
Time to mechanical ventilation liberation (extubation), time to ICU and hospital discharge
Time frame: Through study completion, an average of 2 years
Time to emergence from posttraumatic amnesia
Time from randomisation to emergence from posttraumatic amnesia
Time frame: Through study completion, an average of 2 years
Cognitive recovery
Brief cognitive assessment in traumatology (EXACT) score (0-100 points); higher scores reflect better function
Time frame: Through study completion, an average of 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal