News and Events
SmartTots: Building Community and Advocating for Important Research
SmartTots pediatric anesthetic neurotoxicity thought leaders discuss the current status of the field and provide insights into the future of the research. View on YouTube.
Pediatric Anesthetic Neurotoxicity: Finding Ways to Move Forward
Pediatric anesthetic neurotoxicity investigators discuss the state of the research and identify compelling ways to move the field forward. View on YouTube.
Pediatric Anesthetic Neurotoxicity: Designing the Proper Study
Pediatric anesthetic neurotoxicity thought leaders ponder the feasibility of designing and conducting studies that successfully isolate the effects of anesthetics from the effects of the procedure or patient’s underlying condition. View on YouTube.
Pediatric Anesthetic Neurotoxicity: The Pre-Clinical Journey
Pediatric anesthetic neurotoxicity researchers discuss how pre-clinical studies are providing insight into the mechanisms of neurotoxicity, and the impact on the future of clinical studies. View on YouTube.
SmartTots – Perspectives from the Front Lines
Millions of children undergo surgery annually. Recent studies suggest there may be reason for concern. This video, featuring Dr. Dean Andropoulos, Dr. Peter Davis, and Dr. Caleb Ing, provides a summary as to why research is needed and the type that is needed.
Pediatric anesthetic neurotoxicity has been a concern of clinicians and investigators for more than 20 years. Hundreds of preclinical studies and dozens of clinical studies including PANDA, GAS, and MASK have been undertaken during this time. The results have been mixed. The TREX (Toxicity Remifentanil DEXmedetomidine) trial began in 2017 and set out to study prolonged anesthetic exposure effects and address an important data gap – whether a dexmedetomidine-based anesthetic is associated with better neurodevelopmental outcomes. The study is a Phase III, randomized, active controlled, parallel group, blinded evaluator, multicenter, multinational, superiority trial comparing neurological outcome after standard sevoflurane anesthesia with dexmedetomidine/remifentanil, and low dose sevoflurane anesthesia in children aged less than 2 years undergoing anesthesia of 2 h or longer. There are a total of 20 sites enrolling patients: 7 in Australia, 5 in the U.S. and 8 in Italy with a variety of surgeries being studied at each site. The TREX Trial Investigators recently met a major milestone, the completion of enrollment of 450 trial subjects. The study subjects will return at age 3 years for a battery of neuropsychological testing, including general intelligence, language, fine and gross motor skills, behavioral testing and parent behavioral questionnaires. Once complete in the next 2-3 years, the TREX Trial will make an important contribution to the knowledge about the effects of anesthesia in infants and young children; an issue that potentially affects millions of children globally who undergo anesthesia and surgery each year.
During the 2000’s, preclinical research studies began to find that laboratory animals exposed to commonly used anesthetic and sedative drugs early in life showed changes to the brain and nervous system that interfered with memory and learning. Additional research during this time set off alarms for the Food and Drug Administration (FDA), parents, and the anesthesia practitioner community. The FDA held its first Advisory Committee hearing on this issue in 2007. As an outcome of that meeting, representatives from the FDA reached out to the International Anesthesia Research Society (IARS) in 2008 with the idea of forming a Public Private Partnership to address these new, startling findings. IARS was uniquely positioned to partner with the FDA due to its non-political collaborative mission, infrastructure, expertise and commitment to research, education and advancing the specialty.
IARS is pleased to announce the funding of two new research studies totaling $309,000, aimed at addressing remaining pediatric anesthetic neurotoxicity questions. IARS, and its generous members and donors, have provided the needed funding to continue the work that the SmartTots initiative began ten years ago in partnership with the FDA. Since its inception, SmartTots has worked in collaboration with investigators from around the world to make anesthesia and surgery safe for our most vulnerable population. Recent investigations have provided data demonstrating certainty that anesthetic agents disrupt neurodevelopment in animal models. However, the evidence in humans continues to be mixed. The funding of these two new projects will start to unravel some of the remaining quandaries in this important area of research.
Mark your calendar for this upcoming event to hear the latest pediatric anesthetic neurotoxicity news from our distinguished panel of experts. Join SmartTots and world-renowned scientists as they discuss the up-to-the-minute findings and progress of the research – clinical, pre-clinical, in vitro, they’ll discuss it all!
The IARS announces the appointment of Dean Andropoulos, MD, M.H.C.M. as the Medical Officer of SmartTots. Dr. Andropoulos is an established clinical researcher, and a board-certified physician in Anesthesiology and Pediatric Anesthesiology. He is...
Best Pharmaceuticals for Children Act (BPCA) Priority Releases 2020-2021 List of Needs in Pediatric Therapeutics
The National Institutes of Health (NIH) recently announced an updated BPCA Priority List of Needs in Pediatric Therapeutics. In an ongoing effort to improve the level of information on the safe and effective use of pharmaceuticals used to treat children, the BPCA requires that the NIH poll pediatric experts annually to identify the latest, highest priority needs.