$ 33 million to support study comparing anesthetic drugs – Washington University School of Medicine in St. Louis
More than 50,000 surgical patients undergo general anesthesia every day in the United States, but clinicians and scientists lack evidence to indicate which types of anesthetic drugs work best for patients.
A new study by researchers at Washington University School of Medicine in St. Louis and the University of Michigan will compare intravenous propofol to inhaled anesthetics to determine which of the common anesthetics offer patients better recovery experiences and better clinical results.
With a $ 33 million grant from the Patient-Centered Outcomes Research Institute (PCORI), researchers will coordinate a study called THRIVE – Trajectories of Recovery After Intravenous Propofol vs. Inhaled Volatile Anesthesia. The 6.5-year study will be conducted in clinical centers that are part of the Multicenter Perioperative Outcomes Group (MPOG), for which the University of Michigan is the coordinating center.
Other centers within the MPOG group, including the University of Washington, University of Pennsylvania, and Stanford University, will design and plan the study. A dozen other MPOG clinical centers will recruit patients.
Sachin Kheterpal, MD, associate dean for information technology research and professor of anesthesiology at the University of Michigan and Michael Avidan of the University of Washington, MBBCh, Dr. Seymour and Rose T. Brown professor and head of the anesthesiology department, are the principal investigators of the study.
“General anesthesia is widely regarded as one of the most important medical advances in history, enabling millions of people to safely undergo invasive surgery without suffering,” said Avidan. “The THRIVE trial is designed to answer fundamental questions about which of the two primary anesthesia techniques provides a superior experience for patients during the recovery period, without compromising safety. “
Intravenous propofol and inhaled anesthetics have both been used for many decades. Both techniques have a well-established history of safety and effectiveness, and both are used daily in surgeries performed across the country and around the world. In this study, researchers will focus on the quality of postoperative recovery – one day and 30 days after surgery – as well as the incidence of involuntary intraoperative consciousness, a rare complication in which a patient briefly awakens during a procedure and becomes aware of what’s going on.
“We are seeing variations in the experience of patients on a daily basis – recovery after surgery and anesthesia can range from a few hours to a few months,” said Kheterpal, who is also MPOG research director. “This study aims to help patients recover as quickly as possible so that they can resume their daily lives, and we are delighted to receive support from PCORI as we embark on this multi-center study because we believe this work has the potential to rapidly inform and improve perioperative patient care.
The trial will include 12,500 adult patients undergoing elective non-cardiac surgery. Patients eligible to participate in the study will be invited prior to surgery. If they consent, they will be randomized to receive either intravenous propofol or inhaled anesthetics.
Some patients will receive fitness trackers or smartwatches in the days or weeks before and after surgery so researchers can get details about their standard activity levels, heart rate, sleep patterns, and more. health signals. After surgery, all patients in the study will receive a smartphone app or website link to submit information about their recovery. Study staff will also follow up patients for up to 90 days to monitor each patient’s recovery and related outcomes important to patients, such as postoperative delirium or confusion.
Twelve centers within the MPOG group will serve as clinical sites. These sites will be chosen to represent various geographic locations, and they will be a mix of academic and community health centers. The researchers plan to launch a pilot study on 200 patients over the next few months, and the full trial on 12,500 patients will follow.