ABSTRACT
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.
Subject(s)
Anesthetics, Intravenous/administration & dosage , Consciousness/drug effects , Drug Delivery Systems , Hypnotics and Sedatives/administration & dosage , Anesthetics, Intravenous/adverse effects , Anesthetics, Intravenous/blood , Anesthetics, Intravenous/pharmacokinetics , Device Approval , Diffusion of Innovation , Drug Delivery Systems/instrumentation , Drug Dosage Calculations , Drug Monitoring , Equipment Design , Humans , Hypnotics and Sedatives/adverse effects , Hypnotics and Sedatives/blood , Hypnotics and Sedatives/pharmacokinetics , Infusions, Intravenous , Models, Biological , Monitoring, Intraoperative , SoftwareABSTRACT
Target-controlled infusion (TCI) is a technique of infusing IV drugs to achieve a user-defined predicted ("target") drug concentration in a specific body compartment or tissue of interest. In this review, we describe the pharmacokinetic principles of TCI, the development of TCI systems, and technical and regulatory issues addressed in prototype development. We also describe the launch of the current clinically available systems.
