Hemodynamic impact of remimazolam versus propofol during painless colonoscopy in older adults: A multicenter, single-blind, randomized controlled trial

BACKGROUND: Since older patients are at high risk of hypotension and hypoxia during anesthesia, it is crucial to choose safe sedatives. OBJECTIVES: To compare the efficacy and safety of remimazolam with propofol in elderly patients undergoing endoscopic procedures. MATERIAL AND METHODS: This multicenter, single-blind, randomized study included patients aged ≥65 years (American Society of Anesthesiologists (ASA) physical status I-III) who were randomized in a 1:1 ratio to receive either remimazolam (0.1-0.2 mg/kg) or propofol (0.3-0.5 mg/kg). The primary endpoint was the rate of occurrence of hypotensive events. Secondary endpoints included time to patient unresponsiveness and time to awakening (defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 and ≥4), time to leaving the operating room, cognitive function assessment (using the Mini-Cog test), and additional parameters. RESULTS: A total of 300 patients aged ≥65 years were enrolled. Patients who received remimazolam (n = 132) experienced a significantly lower incidence of intraoperative hypotension compared with those treated with propofol (n = 138) (56.8% vs 82.6%, p < 0.001). The median time to reach a MOAA/S score of 3 was shorter in the remimazolam group than in the propofol group (1.17 min [interquartile range (IQR): 0.85-1.44] vs 1.33 min [IQR: 0.88-2.00], p = 0.041). At 10 min post-awakening, the median Ramsay sedation score was lower in the remimazolam group (2.03 ±0.17 vs 2.14 ±0.35, p = 0.001). Tukey's post hoc analysis showed a significant decline in cognitive scores before and after anesthesia in the propofol group (p = 0.002), whereas no significant change was observed in the remimazolam group (p = 0.658). There was no significant difference in treatment-related adverse events (AEs) between the 2 groups. CONCLUSIONS: Remimazolam significantly reduced the incidence of intraoperative hypotension during colonoscopy, providing a safer sedative option for elderly patients and supporting its use as a preferred agent in this population.