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Perioperative Epidural Trial (POET) Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221260
First Posted: September 22, 2005
Last Update Posted: September 25, 2008
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.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia
  Purpose
To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial

Condition Intervention
Post Operative Pain Control Procedure: anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Perioperative Epidural Trial (POET) Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure

Secondary Outcome Measures:
  • DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension

Estimated Enrollment: 250
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: anesthesia
    Intraoperative general anesthesia AND postoperative IV narcotic analgesia.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects at high risk of cardio-respiratory complications post operatively.

Exclusion Criteria:

Contraindication to epidural anesthesia

  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): NCT00221260


Locations
Canada, British Columbia
Vancouver General Hospital, Clinical Health Research Unit
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Peter Choi, MD University of British Columbia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Peter Choi, University of British Columbia
ClinicalTrials.gov Identifier: NCT00221260     History of Changes
Other Study ID Numbers: C04-0078
04-3046
First Submitted: September 18, 2005
First Posted: September 22, 2005
Last Update Posted: September 25, 2008
Last Verified: September 2008

Keywords provided by University of British Columbia:
Analgesia
anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs