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Clinical Trials/NCT00221260
NCT00221260CompletedNot Applicable

Perioperative Epidural Trial (POET) Pilot Study

University of British Columbia2 sites in 1 country250 target enrollmentStarted: September 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
250
Locations
2
Primary Endpoint
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Contraindication to epidural anesthesia

Outcomes

Primary Outcomes

Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure

Secondary Outcomes

  • DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension

Investigators

Sponsor Class
Other

Study Sites (2)

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