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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01378741
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Delirium Cardiac Disease Drug: Propofol Drug: Dexmedetomidine

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Study Start Date : April 2011
Primary Completion Date : July 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The total cost for each patient [ Time Frame: Up to 7 days or discharge ]
    Summation of direct-variable, direct-fixed, and overhead costs


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378741


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: George Djaiani, MD Toronto General Hospital, UHN
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01378741     History of Changes
Other Study ID Numbers: UHN10-0771A
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Delirium
Heart Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cardiovascular Diseases
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Molecular Mechanisms of Pharmacological Action