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Perioperative Epidural Trial (POET) Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00221260
First received: September 18, 2005
Last updated: September 24, 2008
Last verified: September 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Perioperative Epidural Trial (POET) Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Peter Choi, University of British Columbia
ClinicalTrials.gov Identifier: NCT00221260     History of Changes
Other Study ID Numbers: C04-0078, 04-3046
Study First Received: September 18, 2005
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Analgesia
anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014