An interventional study of Propofol and Dexmedetomidine in Delirium and Cardiac Disease, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.
The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 185 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Drug: Propofol
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
Drug: Dexmedetomidine
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Also known as: Diprivan
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
Also known as: Precedex
Dichotomous outcome, a number of patients with delirium in the two study groups.
Assessment of delirium will be performed utilizing the CAM-ICU
Time frame: up to 7 days postoperatively or discharge
The total cost for each patient
Summation of direct-variable, direct-fixed, and overhead costs
Time frame: Up to 7 days or discharge
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto