NCT01378741

Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium
• Cardiac Disease

Interventions

Type	Name	Description
DRUG	Propofol	Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
DRUG	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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-07-01
• Completion: 2015-04-01
• First posted: 2011-06-22
• Last updated: 2015-04-21

Locations

1 site across 1 country: Canada