This randomized double-blind trial enrolled 150 ASA I-II adults aged 18–59 years in a single-center setting for gastroscopy. Participants received remimazolam at 0, 0.05, 0.1, 0.15, or 0.2 mg·kg−1, with a control group receiving propofol titrated to achieve adequate sedation.
The primary outcome was propofol effect-site EC50 and propofol requirement. The EC50 was reduced in a dose-dependent manner from 3.05 μg·mL−1 at 0.05 mg·kg−1 to 1.47 μg·mL−1 at 0.2 mg·kg−1 (95% CI, 2.88–3.21 at 0.05 mg·kg−1; 95% CI, 1.30–1.64 at 0.2 mg·kg−1). Propofol requirement decreased 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.
Secondary outcomes showed no significant differences in procedure duration or PACU duration among groups. The incidence of sedation-related adverse events was comparable among groups. Serious adverse events and discontinuations were not reported.
Key limitations include the single-center design and lack of reported follow-up duration. The practice relevance notes that 0.1 mg·kg−1 appeared to offer a favorable balance between reduced propofol requirement and recovery profile, supporting its clinical feasibility. These findings suggest a potential sedation-sparing effect but require further validation.
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IntroductionPropofol-based sedation for gastroscopy is effective but may cause dose-dependent cardiorespiratory depression; therefore, optimizing adjunct strategies to reduce propofol exposure is clinically important.MethodsWe 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.ResultsRemimazolam 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.DiscussionAdjunctive remimazolam provided a dose-dependent propofol-sparing effect during gastroscopy sedation. Among the tested doses, 0.1 mg·kg−1 appeared to offer a favorable balance between reduced propofol requirement and recovery profile, supporting its clinical feasibility under the conditions studied.Clinical Trial RegistrationChinese Clinical Trial Registry, identifier ChiCTR2400094449.