The Peri-Operative Epidural Trial pilot study

ISRCTN	ISRCTN35629817
DOI	https://doi.org/10.1186/ISRCTN35629817
ClinicalTrials.gov number	NCT00221260
Secondary identifying numbers	MCT-73644

Submission date: 26/09/2005
Registration date: 26/09/2005
Last edited: 19/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/05/2005
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

Canada

Study participating centre

University of British Columbia

Vancouver
V5Z 4E3
Canada

Sponsor information

Vancouver Coastal Health Research Institute, University of British Columbia (Canada)
Not defined

828 West 10th Avenue
Vancouver
V5Z 1L8
Canada

Email	cheryl.davies@vch.ca
"ROR"	https://ror.org/03rmrcq20

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73644)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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