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.