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

April 17, 2015 updated by: University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Propofol
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 a propofol 2-6mg/kg infusion until tracheal extubation
Other Names:
  • Diprivan
ACTIVE_COMPARATOR: 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.
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.
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 7 days postoperatively or discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total cost for each patient
Time Frame: Up to 7 days or discharge
Summation of direct-variable, direct-fixed, and overhead costs
Up to 7 days or discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: George Djaiani, MD, Toronto General Hospital, UHN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (ESTIMATE)

June 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN10-0771A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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