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ISRCTN
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ISRCTN35629817
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ClinicalTrials.gov identifier
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NCT00221260
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Public title
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The Peri-Operative Epidural Trial pilot study
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Scientific title
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Peri-operative epidural in patients with moderate or high risk for cardiorespiratory events who are undergoing non-cardiothoracic surgery: a randomised controlled trial
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Acronym
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POET
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Serial number at source
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MCT-73644
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Study hypothesis
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Enrolling patients into the above study is still feasible in the current clinical setting.
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Lay summary
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Ethics approval
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Ethics approval received from the Clinical Research Ethics Board of the University of British Columbia on the 31st March 2005.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Postoperative cardio-respiratory complications
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Participants - inclusion criteria
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Any patient undergoing non-cardiopulmonary surgery who:
1. Is greater than or equal to 45 years old, either sex
2. Has an expected length of stay greater than or equal to 48 hours
3. Is undergoing a procedure amenable to postoperative epidural analgesia
4. Fulfils any six criteria for moderate to high cardiorespiratory risk
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Participants - exclusion criteria
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1. Is pregnant or planning to become pregnant before surgery
2. Has a contraindication to epidural analgesia
3. Had a prior adverse reaction to local anesthetics or narcotics
4. Had coronary artery bypass graft surgery with complete revascularisation in the preceding 5 years and has no evidence of cardiac ischemia since the procedure
5. Has pneumonia in the preoperative period
6. Is intubated or mechanically ventilated prior to surgery
7. Has concomitant life-threatening disease likely to limit life expectancy to less than 30 days
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Anticipated start date
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01/05/2005
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Anticipated end date
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30/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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250
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Interventions
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Control:
Intraoperative general anesthesia and postoperative intravenous narcotic analgesia.
Intervention:
Intraoperative neuraxial (epidural or spinal) ± general anesthesia and postoperative epidural analgesia.
Trial details received: 12 September 2005
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Primary outcome measure(s)
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Rates of enrolment, follow-up, and crossover.
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Secondary outcome measure(s)
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1. Combined 30-day outcome of all-cause mortality, nonfatal myocardial infarction, cardiac arrest, postoperative pneumonia, and respiratory failure
2. Other clinical outcomes: deep vein thrombosis, pulmonary embolism, transient ischemic attacks, stroke, and congestive heart failure during first 30 post-operative days
3. Safety outcomes: clinically significant bradycardia or hypotension
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73644)
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Trial website
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http://www.crsu.ca
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/19247497
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Contact name
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Dr
Peter T
Choi
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Address
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University of British Columbia
Department of Anesthesiology
Pharmacology & Therapeutics
910 West 10th Avenue, Room 3200
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City/town
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Vancouver
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Zip/Postcode
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V5Z 4E3
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Country
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Canada
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Tel
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+1 604-875-4111 (68433)
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Fax
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+1 604-875-5344
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Email
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petert.choi@vch.ca
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Sponsor
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Vancouver Coastal Health Research Institute, University of British Columbia (Canada)
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Address
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828 West 10th Avenue
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City/town
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Vancouver
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Zip/Postcode
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V5Z 1L8
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Country
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Canada
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Email
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cheryl.davies@vch.ca
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Date applied
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26/09/2005
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Last edited
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19/06/2009
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Date ISRCTN assigned
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26/09/2005
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