• BMC anesthesiology · May 2024

    Randomized Controlled Trial

    The 90% effective dose (ED90) of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP.

    • Yan Guo, Shu-An Dong, Jia Shi, Hui-Rong Chen, Sha-Sha Liu, Li-Li Wu, Jing-Hua Wang, Li Zhang, Huan-Xi Li, and Jian-Bo Yu.
    • Department of Anesthesiology, Heji Hospital Affiliated to Changzhi Medical College, Changzhi Medical College, Changzhi, Shanxi, China.
    • BMC Anesthesiol. 2024 May 14; 24 (1): 174174.

    BackgroundCompared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, this study aims to determine the 90% effective dose (ED90) of remimazolam to inhibit responses to insertion of a duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).MethodsA dose-response study was carried out undergoing ERCP who received remimazolam-alfentanil anesthesia using 10 µg/kg of alfentanil between September 2021 and November 2021. The initial dose of remimazolam was 0.2 mg/kg. The dose was then decided based on the responses of earlier patients by exploiting the sequential ascend and descend according to a 9: 1 biased coin design. Upon failure, the dose of remimazolam was increased by 0.025 mg/kg in the next patient. When the insertion was successful, the succeeding patient was randomized to an identical dose or a dose that was lower by 0.025 mg/kg.The ED90 of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP was calculated. Adverse events and complications of remimazolam were recorded.ResultsA total of 55 elderly patients (age > 65) were included in the study. 45 successfully anesthetized patients, and 10 unsuccessfully. The ED90 of remimazolam was 0.300 mg/kg (95% CI = 0.287-0.320). ED95 was 0.315 (95% CI = 0.312-0.323) and ED99 was 0.323 (95% CI = 0.323-0.325). Among the patients, 9 patients developed hypotension, 2 patients developed bradycardia and 1 patient developed tachycardia, and hypoxia occurred in 2 patients.ConclusionsA loading dose of 0.300 mg / kg of remimazolam for elderly patients undergoing ERCP can safely, effectively, and quickly induce patients to fall asleep and inhibit responses to the insertion of a duodenoscope.Trial RegistrationThe study protocol was registered at the website ClinicalTrials.gov on 22/09/2021(NCT05053763).© 2024. The Author(s).

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