Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial
George A Mashour,
David Clark,
Amy Price,
Graciela Mentz,
Larry Chu,
Cathie Spino,
Michael S Avidan,
Melissa Hicks,
Alex Kronzer,
Mark D Neuman,
Meghan Lane-Fall,
Sachin Kheterpal,
Bethany R Tellor Pennington,
Douglas A Colquhoun,
Mary C Politi,
Allison M Janda,
Steven Thelen-Perry,
Zhenke Wu,
Sathish S Kumar,
Stephen H Gregory,
Chelsea Cloyd,
Michelle T. Vaughn,
Laura Swisher,
Mara Bollini,
Philip E. Vlisides,
Heidi Klosterman,
Linda Robison,
Hugo Campos,
Bruce L. Hall,
Nicole A. Pescatore,
Roya Saffary,
Leon du Toit,
Bernadette Henrichs,
Brian Torres,
Ralph Dacey,
Nastassjia G. deBourbon,
Jennifer Carron,
Karam Atli,
Sherry McKinnon,
Arbi Ben Abdallah
Affiliations
George A Mashour
Center for Consciousness Science, University of Michigan, Ann Arbor, Michigan, USA
David Clark
Department of Experimental Psychology, University of Oxford, Oxford, UK
Amy Price
patient editor
Graciela Mentz
Anesthesiology, Michigan Medicine, Ann Arbor, Michigan, USA
Larry Chu
Cathie Spino
University of Michigan, Ann Arbor, United States of America
Michael S Avidan
Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
Melissa Hicks
Alex Kronzer
Mark D Neuman
Anesthesiology & Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Meghan Lane-Fall
Center for Healthcare Improvement and Patient Safety, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Sachin Kheterpal
Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA
Bethany R Tellor Pennington
Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
Douglas A Colquhoun
Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA
Mary C Politi
Department of Surgery, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA
Allison M Janda
Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA
Steven Thelen-Perry
Biostatistics, University of Michigan, Ann Arbor, Michigan, USA
Zhenke Wu
Biostatistics, University of Michigan, Ann Arbor, Michigan, USA
Sathish S Kumar
Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA
Stephen H Gregory
Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA
Introduction Millions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA.Methods and analysis This protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described.Ethics and dissemination This study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.Trial registration number NCT05346588.
