Contact information
Type
Scientific
Primary contact
Dr Peter T Choi
ORCID ID
Contact details
University of British Columbia
Department of Anesthesiology
Pharmacology & Therapeutics
910 West 10th Avenue
Room 3200
Vancouver
V5Z 4E3
Canada
+1 604-875-4111 (68433)
petert.choi@vch.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00221260
Protocol/serial number
MCT-73644
Study information
Scientific title
Peri-operative epidural in patients with moderate or high risk for cardiorespiratory events who are undergoing non-cardiothoracic surgery: a randomised controlled trial
Acronym
POET
Study hypothesis
Enrolling patients into the above study is still feasible in the current clinical setting.
Ethics approval
Ethics approval received from the Clinical Research Ethics Board of the University of British Columbia on the 31st March 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Postoperative cardio-respiratory complications
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Rates of enrolment, follow-up, and crossover.
Secondary outcome measures
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
Overall trial start date
01/05/2005
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
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
Recruitment start date
01/05/2005
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Canada
Trial participating centre
University of British Columbia
Vancouver
V5Z 4E3
Canada
Sponsor information
Organisation
Vancouver Coastal Health Research Institute, University of British Columbia (Canada)
Sponsor details
828 West 10th Avenue
Vancouver
V5Z 1L8
Canada
cheryl.davies@vch.ca
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73644)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/19247497
Publication citations
-
Results
Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H, Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study., PLoS ONE, 2009, 4, 2, e4644, doi: 10.1371/journal.pone.0004644.