The goal of this multi-centre phase I/II open-label, single-arm study is to determine the feasibility, optimal dose, and preliminary efficacy of dexmedetomidine to manage agitated delirium among patients near the end of life followed by a palliative care provider in a non-monitored setting. Fifty patients will receive dexmedetomidine (0.4 mcg/kg/hour, titrated up to 1.0 mcg/kg/hour) subcutaneously. Feasibility (recruitment rate, cost), safety (rate of adverse events), dosing, and preliminary efficacy (agitation, delirium severity) will be measured.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Dosing - Therapeutic Dose
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Dosing - Time
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Bradycardia
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Hypotension
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Number of Participants With Adverse Events - Skin Tolerability
Timeframe: Enrollment to study withdrawal, hospital discharge, or death, whichever is first
Recruitment Rate
Timeframe: Through study completion, up to 1 year
Cost
Timeframe: Through study completion, up to 13 months
Baseline Agitation
Timeframe: Baseline
Baseline Delirium Severity
Timeframe: Baseline
Change in Agitation
Timeframe: Measured at Day 1 - 1 hour post administration, one hour post any dose change, and once daily from Day 1 to intervention completion (up to 13 months)
Change in Delirium Severity
Timeframe: Measured every 8 hours from Day 1 to intervention completion (up to 13 months)