The Peri-Operative Epidural Trial pilot study

ISRCTN	ISRCTN35629817
DOI	https://doi.org/10.1186/ISRCTN35629817
ClinicalTrials.gov (NCT)	NCT00221260
Protocol serial number	MCT-73644
Sponsor	Vancouver Coastal Health Research Institute, University of British Columbia (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73644)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter T Choi
Scientific

University of British Columbia
Department of Anesthesiology
Pharmacology & Therapeutics
910 West 10th Avenue, Room 3200
Vancouver
V5Z 4E3
Canada

Phone	+1 604-875-4111 (68433)
Email	petert.choi@vch.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study acronym	POET
Study objectives	Enrolling patients into the above study is still feasible in the current clinical setting.
Ethics approval(s)	Ethics approval received from the Clinical Research Ethics Board of the University of British Columbia on the 31st March 2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Rates of enrolment, follow-up, and crossover.
Key secondary outcome measure(s)	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
Completion date	30/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	30/04/2006

University of British Columbia

Vancouver
V5Z 4E3
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/06/2009		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes