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

This study is currently recruiting participants.
Verified February 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01378741
First received: June 20, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Delirium
Cardiac Disease
 Drug: Propofol
Drug: Dexmedetomidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Dichotomous outcome, a number of patients with delirium in the two study groups. [ Time Frame: up to 7 days postoperatively or discharge ] [ Designated as safety issue: No ]
    Assessment of delirium will be performed utilizing the CAM-ICU


Secondary Outcome Measures:
  • The total cost for each patient [ Time Frame: Up to 7 days or discharge ] [ Designated as safety issue: No ]
    Summation of direct-variable, direct-fixed, and overhead costs


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Precedex

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378741

Contacts
Contact: George Djaiani, MD 416-340-4800 ext 6205 george.djaiani@uhn.on.ca
Contact: Jo Carroll, BHA 416-340-4800 ext 3243 jo.carroll@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jo Carroll, BHA     416 340-4800 ext 3243     jo.carroll@uhn.on.ca    
Sub-Investigator: Rita Katznelson, MD            
Sponsors and Collaborators
University Health Network, Toronto
Hospira, Inc.
Investigators
Principal Investigator: George Djaiani, MD Toronto General Hospital, UHN
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01378741     History of Changes
Other Study ID Numbers: UHN10-0771A
Study First Received: June 20, 2011
Last Updated: February 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
delirium
cardiac surgery
postoperative sedation

Additional relevant MeSH terms:
Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Heart Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Cardiovascular Diseases
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013