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Perioperative Epidural Trial (POET) Pilot Study

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ClinicalTrials.gov Identifier: NCT00221260
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 25, 2008
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Post Operative Pain Control Procedure: anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Perioperative Epidural Trial (POET) Pilot Study
Study Start Date : September 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia


Intervention Details:
  • Procedure: anesthesia
    Intraoperative general anesthesia AND postoperative IV narcotic analgesia.


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

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


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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


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

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 Posted: September 22, 2005    Key Record Dates
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