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

NCT01378741 | Completed

• 1 other identifier: UHN10-0771A
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Cardiac Disease

Keywords

delirium; cardiac surgery; postoperative sedation

Outcome Measures

Primary Outcomes (1)

• Dichotomous outcome, a number of patients with delirium in the two study groups.

  Assessment of delirium will be performed utilizing the CAM-ICU

  up to 7 days postoperatively or discharge

Secondary Outcomes (1)

• The total cost for each patient

  Up to 7 days or discharge

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

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

Interventions

Propofol DRUG

Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation

Also known as: Diprivan

Propofol

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.

You may not qualify if:

• Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Delirium; Heart Diseases

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• George Djaiani, MD

  Toronto General Hospital, UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

CA (1)