Comparison of 95% effective dose of Remimazolam and Propofol for
gastroscopy sedation on elderly patients: a single-center randomized
controlled trial
Abstract
Aim: Advanced age is an important risk factor for adverse events during
procedural sedation. Remimazolam is safe and effective in adults’
gastroscopy sedation. The ideal dose and availability for elderly
patients are not well known. We aim to investigate its 95% effective
dose (ED95) for elderly patients undergoing gastroscopy, and to assess
its safety and efficacy, with propofol as the comparison. Methods: The
trial consists of two parts, patients who are over 65 and scheduled for
elective outpatient painless gastroscopy were enrolled. In the first
part, Dixon’s up-and-down methodology was used to determine the ED95 of
remimazolam and propofol for inhibiting body movement during
gastroscopic insertion, in combination with 0.2μg/kg remifentanil. In
the second part, patients in each group received 0.2μg/kg remifentanil
and the ED95 dose of the study drug for sedation induction, adding
supplemental doses to maintain sedation depth when necessary. The
primary outcome was the incidence of adverse events. The secondary
outcome was the recovery time. Results: The ED95 of remimazolam and
propofol induction dose were 0.204mg/kg [95% CI (0.175–0.390)
mg/kg] and 1.994 mg/kg [95% CI (1. 739–5.955) mg/kg]
respectively in gastroscopy. Adverse events were reported in 40.6% of
patients in the remimazolam group and 83.1% in the propofol group
(p<0.001), whereas the remimazolam group showed a higher
incidence of hiccup(p=0.017). A shorter time to awakening
(p<0.05) in the remimazolam group was observed. Conclusion:
For elderly patients undergoing gastroscopy, the ED95 dose of
remimazolam is a safer alternative than propofol when inducing the same
sedation depth.