Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620393
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients DEX-TBI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEX-TBI
Brief Summary:
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 its 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None