Comparing Remimazolam and Propofol Intravenous Anesthesia in Patients 45 and Older Undergoing Major Noncardiac Surgery

What this Trial Is About

Researchers are evaluating and comparing the effects of total intravenous anesthesia using remimazolam versus propofol in patients at moderate to high risk undergoing major elective noncardiac surgery under general anesthesia. This randomized controlled trial aims to determine if remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery. The study is conducted by Nanfang Hospital, Southern Medical University and is classified as a phase 4 trial. Participants receive either remimazolam or propofol as anesthesia. Remimazolam is given intravenously at 6-12 mgkgh for induction and 1.0-2.0 mgkgh for maintenance, adjusted to keep the Bispectral Index between 40 and 60. Propofol is administered intravenously at 1.5-2.5 mgkg for induction and 4-12 mgkgh for maintenance, also titrated to maintain the same Bispectral Index range. These dosing strategies help monitor and control anesthesia depth during surgery. During the study, participants will be closely monitored for outcomes including days alive and out of hospital at 30 days after randomization, all-cause mortality within 30 days, length of hospital stay, unplanned re-hospitalizations, postoperative complications, and quality of recovery on the first day after surgery. The trial involves double-blind randomization and includes follow-up assessments at 30 days to gather comprehensive data on recovery and safety.

REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry