|
|||||
|
|
A randomized feasibility trial of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockade: the EPIC study |
|
| Authors: | Duminda N. Wijeysundera MD PhD Peter T. Choi MD Neal H. Badner MD Penelope M. Brasher PhD George K. Dresser MD PhD Diego H. Delgado MD W. Scott Beattie MD PhD |
| Affiliation: | 1. Department of Anesthesia, Toronto General Hospital and University of Toronto, Eaton Wing 3-450, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada 2. Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, ON, Canada 3. Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada 4. Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada 5. Department of Anesthesiology and Perioperative Care, Vancouver Acute, Vancouver, BC, Canada 6. Department of Anesthesia and Perioperative Medicine, University of British Columbia, Kelowna, BC, Canada 7. Department of Statistics, University of British Columbia, Vancouver, BC, Canada 8. Department of Medicine, Western University, London, ON, Canada 9. Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, Toronto, ON, Canada |
| Abstract: | PurposeClonidine may help prevent cardiac complications in patients undergoing non-cardiac surgery and receiving chronic beta-blocker therapy. We conducted a multicentre pilot randomized trial to estimate recruitment rates for a full-scale trial and to assess the safety and tolerability of combining clonidine with chronic beta-blockade.MethodsPatients who were at elevated perioperative cardiac risk, receiving chronic beta-blockade, and scheduled for major non-cardiac surgery were recruited in a blinded (participants, clinicians, outcome assessors) placebo-controlled randomized trial at three Canadian hospitals. Participants were randomized to clonidine (0.2 mg oral tablet one hour before surgery, plus 0.2 mg·day?1 transdermal patch placed one hour before surgery and removed four days after surgery or hospital discharge, whichever came first) or matching placebo. Feasibility was evaluated based on recruitment rates, with each centre being required to recruit 50 participants within 12-18 months. Additionally, we reviewed study drug withdrawals and safety outcomes, including clinically significant hypotension or bradycardia.ResultsEighty-two of the 168 participants were randomized to receive clonidine and 86 to receive placebo. The average time to recruit 50 participants at each centre was 14.3 months. Six patients (7%) withdrew from clonidine, while four (5%) withdrew from placebo. Based on qualitative review, there were no major safety concerns related to clonidine. There was a moderate overall rate of cardiac morbidity, with 18 participants (11%) suffering postoperative myocardial infarction.ConclusionThis pilot randomized trial confirmed the feasibility, safety, and tolerability of a full-scale trial of oral and transdermal clonidine for reducing the risk of cardiac complications during non-cardiac surgery. This trial was registered at www.clinicaltrials.gov: NCT00335582. |
| Keywords: | |
| 本文献已被 SpringerLink 等数据库收录！ | |