Target-controlled infusions (TCIs) have been used in research and clinical practice for >2 decades. Nonapproved TCI software systems have been used during the conduct of almost 600 peer-reviewed published studies involving large numbers of patients. The first-generation pumps were first approved in 1996, and since then an estimated 25,000 units have been sold and used. Second-generation pumps were first approved in 2003. During 2004 to 2013, >36,000 units were sold. Currently, TCI systems are approved or available in at least 96 countries. TCI systems are used to administer propofol and opioids for IV sedation and general anesthesia for millions of patients every year. In countries where TCI systems are approved, nonapproved software is still commonly used in studies of the pharmacology of hypnotics and opioids, because research software offers greater flexibility than approved TCI systems. Research software is also readily integrated into data management modules. Although TCI is a part of established practice around the world, TCI devices have not received regulatory approval in the United States. In the United States, TCI administration of propofol and opioids for sedation and anesthesia is only possible using research software in IRB-approved research studies.
Supplemental Digital Content is available in the text.Published ahead of print October 29, 2015
From the *Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; †Glen Pharma, Knutsford, Cheshire, United Kingdom; ‡Department of Anesthesiology, Intensive Care, Rescue and Pain Medicine, Kantonsspital St. Gallen, St. Gallen, Switzerland; §Faculty of Medicine, Anesthesiology, University of Berne, Berne, Switzerland; and ∥Department of Anesthesia, Ghent University, Gent, Belgium.
Accepted for publication July 27, 2015.
Published ahead of print October 29, 2015
Conflict of Interest: See Disclosures at the end of the article.
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Address correspondence to Anthony R. Absalom, MBChB, FRCA, MD, Department of Anesthesiology, University Medical Center Groningen, P.O. Box 30.001, Groningen 9700 RB, The Netherlands. Address e-mail to firstname.lastname@example.org.