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  • Title: The 50% and 95% effective doses of remimazolam tosilate with adjuvant sufentanil for sedation in patients with liver cirrhosis undergoing oesophagogastric varices screening endoscopy.
    Author: Cao YH, Chi P, Zhou C, Lv WF, Quan ZF, Xue FS.
    Journal: J Clin Pharm Ther; 2022 Dec; 47(12):2068-2073. PubMed ID: 36543252.
    Abstract:
    WHAT IS ALREADY KNOWN AND OBJECTIVE: Sedation is routinely provided for patients undergoing gastrointestinal endoscopy. Remimazolam tosilate is a novel and short-acting sedative agent that has been used for sedation during endoscopic procedures. The optimal dose of remimazolam in gastrointestinal endoscopy for patients with liver cirrhosis has not been elucidated. BACKGROUND: To determine the effective dose of remimazolam tosilate with adjuvant sufentanil for sedation in patients with liver cirrhosis undergoing oesophagogastric varices screening endoscopy. MATERIAL AND METHODS: Patients aged 18-65 years with liver cirrhosis undergoing screening endoscopy for oesophagogastric varices were recruited. Sufentanil 0.15 μg/kg was given intravenously at 2 min before administration of remimazolam tosilate. The initial dose of remimazolam was 0.1 mg/kg and adjusted by 0.025 mg/kg as a step size, based on the Dixon and Massay up-and-down sequential method. Inclusion of patients was stopped after eight crossovers and the calculated median effective dose (ED50 ) of remimazolam for successful endoscopy was obtained by calculating the mean of midpoint of all crossovers. Furthermore, a probit regression was applied to establish the dose-response curve of remimazolam and further assess the 95% effective dose (ED95 ) of remimazolam. RESULTS: The calculated ED50 of remimazolam for successful endoscopy using the mean of midpoint of all crossovers was 0.097 mg/kg (95% CI, 0.004-0.099 mg/kg). Using the probit regression analysis, the ED50 and ED95 of remimazolam for successful endoscopy was 0.097 mg/kg (95% CI, 0.004-0.099 mg/kg) and 0.107 mg/kg (95% CI, 0.103-0.336 mg/kg), respectively. No adverse events were observed throughout the study period. CONCLUSIONS: This pilot study suggests that the ED50 and ED95 of remimazolam tosilate with adjuvant sufentanil for sedation in liver cirrhosis patients undergoing oesophagogastric varices screening endoscopy was 0.097 and 0.107 mg/kg, respectively.
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