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Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision
Authors:Thomas Fuchs-Buder  Sorin J Brull  Malin Jonsson Fagerlund  J Ross Renew  Guy Cammu  Glenn S Murphy  Michiel Warlé  Matias Vested  Béla Fülesdi  Reka Nemes  Malachy O Columb  Daniela Damian  Peter J Davis  Hajime Iwasaki  Lars I Eriksson
Institution:1. Department of Anaesthesia, Critical Care & Perioperative Medicine, University Hospital Nancy, Nancy, France;2. Mayo Clinic College of Medicine and Science, Jacksonville, Florida, USA;3. Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden;4. Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, Florida, USA;5. Department of Anesthesiology, Critical Care and Emergency Medicine, Aalst, Belgium;6. Department of Anesthesiology, NorthShore University HealthSystem, Chicago, Illinois, USA;7. Department of Surgery, Radbound University Medical Center, Nijmegen, The Netherlands;8. Department of Anesthesia Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;9. Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary;10. Anaesthesia & Intensive Medicine, Manchester University Hospitals NHS Foundation Trust, Manchester, UK;11. Anesthesiology and Perioperative Medicine, UPMC Children's Hospital, Pittsburgh, Pennsylvania, USA;12. Anesthesia and Pediatrics, UPMC Children's Hospital, Pittsburgh, Pennsylvania, USA;13. Department of Anesthesiology and Crtical Care Medicine, Asahikawa Medical University, Asahikawa, Japan
Abstract:The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby-Mogensen et al., Acta Anaesthesiol Scand 1996, 40 , 59–74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs-Buder et al., Acta Anaesthesiol Scand 2007, 51 , 789–808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three-dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high-quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus-based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.
Keywords:depth of neuromuscular blockade  neuromuscular monitoring  neuromuscular research  pharmacodynamics  postoperative pulmonary complications  time course of neuromuscular blockade
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