Dose optimization of remimazolam as an adjunct to propofol for gastroscopy sedation: a randomized double-blind trial
Abstract
Introduction: Propofol-based sedation for gastroscopy is effective but may cause dose-dependent cardiorespiratory depression; therefore, optimizing adjunct strategies to reduce propofol exposure is clinically important.
Methods: We conducted a prospective, single-center, randomized, double-blind, dose-response trial to evaluate the propofol-sparing effect of remimazolam during procedural sedation for gastroscopy. A total of 150 ASA I-II adults aged 18-59 years were randomly assigned to receive remimazolam 0, 0.05, 0.1, 0.15, or 0.2 mg·kg-1, and propofol was titrated to achieve adequate sedation. The primary outcomes were the propofol effect-site EC50 and propofol requirement (mg·kg-1·min-1). Secondary outcomes included recovery profiles, post-anesthesia care unit (PACU) duration, and sedation-related adverse events.
Results: Remimazolam reduced the propofol EC50 in a dose-dependent manner, from 3.05 (95% CI, 2.88-3.21) μg·mL-1 at 0.05 mg·kg-1 to 1.47 (95% CI, 1.30-1.64) μg·mL-1 at 0.2 mg·kg-1, and decreased propofol requirement from 0.587 ± 0.193 mg·kg-1·min-1 in the control group to 0.414 ± 0.121 mg·kg-1·min-1 at 0.1 mg·kg-1 and 0.298 ± 0.088 mg·kg-1·min-1 at 0.2 mg·kg-1. Procedure duration and PACU duration did not differ significantly among groups, and the incidence of sedation-related adverse events was comparable.
Discussion: Adjunctive remimazolam provided a dose-dependent propofol-sparing effect during gastroscopy sedation. Among the tested doses, 0.1 mg·kg-1 appeared…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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