Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients

Launched by CENTRE INTEGRE UNIVERSITAIRE DE SANTE ET SERVICES SOCIAUX DU NORD DE L'ILE DE MONTREAL · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dexmedetomidine on patients who have experienced a traumatic brain injury (TBI) and are experiencing agitation while in the intensive care unit (ICU). Agitation can be a common problem for these patients, often leading to the use of strong medications that may slow down their recovery. The researchers want to see if dexmedetomidine, which has a milder calming effect, can help manage agitation better, allowing patients to recover more effectively.

To participate in this trial, individuals must be at least 18 years old and admitted to the ICU with a moderate or severe TBI, confirmed by a specific scoring system. They should also be on a ventilator and expected to stay in the ICU for at least 48 hours. However, patients who are at very high risk of dying soon, unable to communicate in English or French, or have certain health conditions may not be eligible. This study is still in the planning stages and has not yet started recruiting participants. If you or a loved one qualify, participating could provide valuable insights into better ways to help TBI patients manage agitation during recovery.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Undergoing mechanically ventilation (of any duration) at the time of assessment.
• • 3. Anticipated ICU stay of 48 hours or more.
• Exclusion Criteria:
• • 1. 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
• • 2. Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)
• • 3. Patients with cognitive impairment as per family evaluation
• • 4. Pregnant or breastfeeding
• • 5. Patients currently receiving DEX or clonidine
• • 6. Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician