Frontiers in medicine · 2026
The 90% effective dose of remimazolam in combination with sufentanil for sedation in patients undergoing gastroscopy.
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Chen Yan, Jin Fan, Wang Wenjie, Wang Hongwei
Аннотация
OBJECTIVE: To determine the 90% effective dose (ED90) of remimazolam in combination with sufentanil for sedation in patients undergoing gastroscopy.
METHODS: Fifty-six patients aged 18-65 years with ASA physical status I-II and a BMI of 18-30 kg/m2 who were scheduled for gastroscopy were enrolled. All patients received 5 μg of sufentanil, followed 3 min later by an initial dose of 5 mg remimazolam. The dose was determined using a two-stage biased-coin design up-and-down sequential method, with each patient's dose based on the response of the preceding patient. Dose adjustments were made in 2.5 mg increments. For failure of sedation (negative response: coughing, body movement, or MOAA/S > 1 during pharyngeal passage), the dose for the next patient was increased deterministically by 2.5 mg; for success of sedation (positive response: MOAA/S ≤ 1), the dose was decreased with 11% probability or kept unchanged with 89% probability. ED90 and its 95% confidence interval (CI) were estimated using isotonic regression with bootstrap resampling. The incidence of adverse events during sedation was recorded.
RESULTS: The ED90 of remimazolam combined with 5 μg of sufentanil was 17.625 mg (95% CI: 15.467-20.000 mg). Six patients experienced coughing, and seven developed transient hypotension during sedation. No other adverse events were observed.
CONCLUSION: The ED90 of remimazolam combined with sufentanil for gastroscopy sedation was 17.625 mg, with a low incidence of adverse events. These results provided a clinically relevant dosing benchmark for this promising drug combination.
METHODS: Fifty-six patients aged 18-65 years with ASA physical status I-II and a BMI of 18-30 kg/m2 who were scheduled for gastroscopy were enrolled. All patients received 5 μg of sufentanil, followed 3 min later by an initial dose of 5 mg remimazolam. The dose was determined using a two-stage biased-coin design up-and-down sequential method, with each patient's dose based on the response of the preceding patient. Dose adjustments were made in 2.5 mg increments. For failure of sedation (negative response: coughing, body movement, or MOAA/S > 1 during pharyngeal passage), the dose for the next patient was increased deterministically by 2.5 mg; for success of sedation (positive response: MOAA/S ≤ 1), the dose was decreased with 11% probability or kept unchanged with 89% probability. ED90 and its 95% confidence interval (CI) were estimated using isotonic regression with bootstrap resampling. The incidence of adverse events during sedation was recorded.
RESULTS: The ED90 of remimazolam combined with 5 μg of sufentanil was 17.625 mg (95% CI: 15.467-20.000 mg). Six patients experienced coughing, and seven developed transient hypotension during sedation. No other adverse events were observed.
CONCLUSION: The ED90 of remimazolam combined with sufentanil for gastroscopy sedation was 17.625 mg, with a low incidence of adverse events. These results provided a clinically relevant dosing benchmark for this promising drug combination.