Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Overview
- Phase
- Not Applicable
- Intervention
- Propofol
- Conditions
- Delirium
- Sponsor
- University Health Network, Toronto
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- Dichotomous outcome, a number of patients with delirium in the two study groups.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.
Exclusion Criteria
- •Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.
Arms & Interventions
Propofol
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
Intervention: Propofol
Dexmedetomidine
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.
Intervention: Dexmedetomidine
Outcomes
Primary Outcomes
Dichotomous outcome, a number of patients with delirium in the two study groups.
Time Frame: up to 7 days postoperatively or discharge
Assessment of delirium will be performed utilizing the CAM-ICU
Secondary Outcomes
- The total cost for each patient(Up to 7 days or discharge)