Monitoring Opioids and Hypnotics to Prevent Organ Dysfunction and Death in Older Adults Undergoing High-Risk Surgery

What this Trial Is About

Intraoperative hypotension, a common issue during surgery, increases the risk of complications and death after surgery, especially in patients who are older and at high postoperative risk. This trial evaluates whether carefully monitoring and optimizing both sedation and pain relief during surgery can reduce organ dysfunction and mortality in these high-risk patients. The study specifically focuses on patients aged 75 and older undergoing high-risk surgery under general anesthesia involving hypnotics and opioids. Participants will be randomly assigned to one of two groups. One group will receive anesthesia guided by advanced monitoring systems that track sedation levels and pain responses using devices like BIS17, SedLine4, Entropy Sensor17, and PMD-2004. The other group will receive standard anesthesia based on the anesthetists clinical judgment without these monitoring tools. The study aims to compare the impact of these approaches on intraoperative hypotension and postoperative outcomes. During the study, researchers will monitor doses of hypnotics and opioids used, the number and duration of hypotensive episodes, and the time spent within target sedation and analgesia ranges. They will also assess postoperative complications such as acute kidney injury, cardiovascular and neurological problems, delirium, respiratory failure, length of intensive care and hospital stays, and mortality within 30 days after surgery. Pain levels and opioid use will be evaluated 48 hours after surgery. The total study duration extends through the postoperative period up to 30 days.

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk