Key result
A perioperative clonidine regimen was feasible to study in patients on chronic beta-blockade, achieving the primary feasibility endpoint with an average recruitment time of 14.3 months per 50 participants at each center.
Why the study?
Does clonidine improve feasibility and safety outcomes in patients on chronic beta-blockade undergoing major non-cardiac surgery?
RCT (n=168)
Double-blind (participants, clinicians, data collectors, and outcome adjudicators)
Computer-generated randomization schedule employing permuted blocks of varying size with stratification by hospital
Yes
Does clonidine improve feasibility and safety outcomes in patients on chronic beta-blockade undergoing major non-cardiac surgery?
Effect estimate: 14.3 months average time
This pilot trial confirmed the feasibility and safety of conducting a full-scale RCT of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockers.
Supports advancing to a definitive RCT of perioperative clonidine; confirms feasibility in beta-blocked patients for non-cardiac surgery.
PURPOSE: Clonidine 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. METHODS: Patients 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. RESULTS: Eighty-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. CONCLUSION: This 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.
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Wijeysundera et al. (2014) conducted an RCT in Elevated perioperative cardiac risk in patients receiving chronic beta-blockade scheduled for major non-cardiac surgery (n=168). Clonidine vs. Matching placebo was evaluated on Feasibility (time to recruit 50 participants per center) (14.3 months average time). A perioperative clonidine regimen was feasible to study in patients on chronic beta-blockade, achieving the primary feasibility endpoint with an average recruitment time of 14.3 months per 50 participants at each center.
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