The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.
Study Type
OBSERVATIONAL
Enrollment
373
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, Canada
Incidence of clinically meaningful hemodynamic abnormality (CMHA)
Clinically meaningful hemodynamic abnormalities (CMHA) consist of (any): * Heart Rate (HR): A native HR \<40 bpm (beats per minute); HR \<50 bpm requiring pharmacological intervention; systolic BP \<80 mm Hg; if pacing wires are in situ, use of a pacemaker after the start of study drug. * Vasoactive Agent Use (i.e. vasopressor or inotrope): the need to add an additional agent to maintain BP; doubling of the dose of any vasoactive agent that was infusing at the start of the study drug. * Paradoxical hypertension: the need to add an additional vasodilating agent for control of hypertension; doubling of the dose of any vasodilating agent that was infusing at the start of the study drug.
Time frame: During the first 2 hours of study drug administration
Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.
Time frame: Maintenance infusion period (2 to 24 hours)
Incidence of adverse events (AEs) between the 3 loading-dose paradigms
Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal
Time frame: Post-dexmedetomidine 24-hour observation period
Incidence of paradoxical hypertension
Time frame: During the first 2 hours of the post-dexmedetomidine observation period
Incidence of paradoxical hypertension
Time frame: Post-dexmedetomidine 24-hour observation period
Amount of analgesics administered
Time frame: 2 hours prior, and for the first 2 hours during, study drug administration
Amount of sedatives administered
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Red Deer Regional Hospital Centre, Alberta Health Services
Red Deer, Alberta, Canada
Unnamed facility
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Capital Health-Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
St. Mary's General Hospital
Kitchener, Ontario, Canada
University Hospital
London, Ontario, Canada
Unnamed facility
Thunder Bay, Ontario, Canada
...and 7 more locations
Time frame: 2 hours prior, and for the first 2 hours during, study drug administration