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

Not Applicable

Completed

• Conditions: Delirium; Cardiac Disease
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT01378741
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Primary Completion: 2014-07
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	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.
Propofol	Propofol	Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation

Primary Outcome Measures

Name	Time	Method
Dichotomous outcome, a number of patients with delirium in the two study groups.	up to 7 days postoperatively or discharge	Assessment of delirium will be performed utilizing the CAM-ICU

Secondary Outcome Measures

Name	Time	Method
The total cost for each patient	Up to 7 days or discharge	Summation of direct-variable, direct-fixed, and overhead costs

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada