Brain-Targeted Goal-Directed Therapy Using Near Infrared Spectroscopy to Reduce Complications in High-Risk Patients Undergoing Major Elective Surgery

What this Trial Is About

Researchers are evaluating the use of Near Infrared Spectroscopy NIRS as a monitoring tool to reduce complications after surgery in high-risk patients. The study focuses on elderly or frail patients with hypertension undergoing major elective surgeries. It aims to understand if maintaining brain oxygen levels through NIRS can improve outcomes and reduce surgery-related problems within 30 days after the operation. In this randomized controlled trial, participants are assigned to one of two groups. The experimental group receives NIRS-targeted goal-directed therapy where brain oxygen saturation is continuously monitored during surgery, and adjustments are made if oxygen levels drop. The control group receives standard care with usual monitoring methods, but NIRS data is recorded without guiding treatment. Both groups undergo major surgeries lasting more than an hour under general anesthesia. During the study, participants will have continuous brain oxygen monitoring and hemodynamic assessments during surgery. Researchers will track complications including cognitive issues like delirium up to 30 days post-surgery. Data on blood pressure, anesthesia levels, fluid use, and vasopressor medications will also be collected. The total study enrollment is 200 patients, and monitoring extends through the post-anesthesia care unit and intensive care unit if applicable.

BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study