Comparison between Propofol and Total Inhalational Anaesthesia on Cardiovascular Outcomes Following On-pump Cardiac Surgery in Higher-Risk Patients – A Randomised Controlled Pilot and Feasibility Study

Objectives Myocardial revascularisation and cardiopulmonary bypass (CPB) can cause ischemia-reperfusion injury, leading to myocardial and other end-organ damage. Volatile anaesthetics protect the myocardium in experimental studies, however there is uncertainty as whether this translates into clinical benefits. Methods In this single blinded parallel group randomised controlled feasibility trial higher-risk patients undergoing elective coronary artery bypass graft surgery with an additive European System for Cardiac Operative Risk Evaluation (EuroScore) > 5 were randomised to receive either propofol or total inhalational anaesthesia for maintenance of anaesthesia. The primary outcome was the feasibility to recruit and randomise 50 patients across two cardiac surgical centres and secondary outcomes included the feasibility of collecting the planned perioperative data and clinically relevant outcomes and assessments of effective patient identification, screening and recruitment. Results All 50 patients were recruited within 11 months in two centres allowing for a 13-month hiatus in recruitment due to the COVID-19 pandemic. Overall, 50/108 (46%) of eligible patients were recruited. One patient withdrew before surgery and one patient did not undergo surgery. All but one completed in-hospital and 30-day follow-up. Conclusions It is feasible to recruit and randomise higher-risk patients undergoing CABG surgery to a study comparing total inhalational and propofol anaesthesia in a timely manner and with high acceptance and completion rates. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04039854 ### Funding Statement This study was funded by the National Institute of Academic Anaesthesia WKR0-2018-0025 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: London - Chelsea Research Ethics Committee Research Ethics Committee (REC) London Centre Skipton House 80 London Road London SE1 6LH I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors