More than 50,000 surgical patients receive anesthetic care in the U.S. each day. But when it comes to deciding between two anesthetic medications that have been in use for decades, clinicians and patients have little scientific evidence to compare effectiveness and risks.
A new study led by University of Michigan and Washington University in St. Louis aims to compare intravenous propofol anesthesia with inhaled potent volatile anesthesia to determine which technique offers a better patient recovery experience and clinical outcomes.
The Patient-Centered Outcomes Research Institute (PCORI) awarded nearly $33 million in funding last month to support THRIVE — Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia. This 6.5-year study will be conducted by the Multicenter Perioperative Outcomes Group (MPOG), for which U-M is the coordinating center. MPOG members U-M, Washington University, University of Pennsylvania, and Stanford University will lead the design and planning of the study with additional MPOG centers enrolling patients. Michigan Medicine’s Department of Anesthesiology and the U-M School of Public Health’s Statistical Analysis of Biomedical and Educational Research Group (SABER), a unit of the department of biostatistics, are leading the Data Coordinating Center activities of THRIVE.
U-M’s Sachin Kheterpal, M.D., MBA, and Washington University’s Michael Avidan, MBBCh, are the study’s co-principal investigators.
“We see variation in patient experience on a daily basis — recovery from surgery and anesthesia can range from a few hours to months. This study is focused on helping patients recover as quickly as possible so that they can get back to their daily routines,” said Kheterpal, a professor of anesthesiology and MPOG research director. “We are thrilled to receive support from PCORI as we embark on this large-scale study, as we believe this work has the potential to rapidly inform and improve perioperative patient care.”
Both intravenous propofol and inhaled volatile anesthetics have been in use for decades, have established safety and efficacy, and are used thousands of times daily in operating rooms across the country. In this study, researchers will compare the quality of recovery in the days after surgery as well as the incidence of the devastating and rare complication of unintended intraoperative awareness with recall.
“General anesthesia is widely regarded as one of the most important medical advances, allowing millions of people to safely undergo invasive procedures without suffering,” said Avidan, the Dr. Seymour and Rose T Brown Professor of Anesthesiology and head of the Department of Anesthesiology. “The THRIVE trial will answer the fundamental question regarding which of the two main anesthetic techniques provides a superior patient experience during the recovery period, without compromising safety.”
The 12,500-patient trial will include adult patients undergoing elective, non-cardiac surgery. Eligible patients will be approached prior to surgery and invited to participate. After consenting to the study, patients will be randomized to one of the two study medications. A subset of patients will be provided a fitness tracker or smartwatch days to weeks before surgery to understand their baseline activity, heart rate, sleep patterns, and other wearable signals. All patients will be provided a smartphone app (or website link) to help with collection of patient reported outcomes. Study personnel will follow up with the patients for up to 90 days to understand changes in recovery, delirium, functional status, and other outcomes important to patients and clinicians alike.
Twelve MPOG member institutions will serve as clinical sites, representing varying geographic locations, as well as a mix of academic and private institutions. Researchers expect to launch a 200-patient pilot program within the year, with the full trial to follow.
“MPOG, with its existing set of collaborators, data collection infrastructure, and engagement with clinicians at the point of care, was designed for projects like THRIVE,” Kheterpal said. “We connect with more than 5,000 anesthesia clinicians every month, including attendings, residents, nurse anesthetists and anesthesia assistants. That’s the type of teamwork and national reach that it takes to answer important questions like this.”
Funding for the study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.