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Background <p>This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy.</p> Methods <p>Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety group (SAS &lt; 50). All patients received intravenous administration of 5&#xa0;µg/kg alfentanil combined with remimazolam besylate. The biased coin design up-and-down sequential method (BCD-UDM) was used to determine the target doses of remimazolam besylate: the initial dose was 0.1&#xa0;mg/kg, with a dose gradient of 0.01&#xa0;mg/kg. If coughing, swallowing, or body movement reactions occurred within the first 2&#xa0;min from the start of gastroscopy, it was considered a positive reaction, and the dose was increased for the next patient. Otherwise, it was considered a negative reaction, and the dose of remimazolam besylate for the next patient was determined according to the BCD-UDM. Discharge time from the recovery room and adverse reactions were recorded. The ED<sub>50</sub>, ED<sub>90</sub>, and their 95% confidence intervals (<i>CI</i>) were calculated.</p> Results <p>The ED<sub>50</sub> and ED<sub>90</sub> of remimazolam besylate in the anxiety group were 0.175&#xa0;mg/kg (95% <i>CI</i>, 0.140–0.240) and 0.251&#xa0;mg/kg (95% <i>CI</i>, 0.173–0.250), respectively. In contrast, the ED<sub>50</sub> and ED<sub>90</sub> of remimazolam besylate in the non-anxiety group were 0.126&#xa0;mg/kg (95% <i>CI</i>, 0.116–0.150) and 0.148&#xa0;mg/kg (95% <i>CI</i>, 0.130–0.160), respectively. The ED<sub>90</sub> equivalent ratio of the non-anxiety group to the anxiety group was 0.59 (95% <i>CI</i>, 0.468–0.710). The discharge time from the recovery room and the incidence of adverse reactions did not differ significantly between the groups.</p> Conclusions <p>When combined with 5&#xa0;µg/kg alfentanil, the ED<sub>50</sub> and ED<sub>90</sub> of remimazolam besylate for inhibiting body movement response within two minutes of gastroscopy in anxious patients were 0.175&#xa0;mg/kg and 0.251&#xa0;mg/kg, respectively. Anxiety increased the requirement for remimazolam besylate in patients undergoing gastroscopy, but it did not increase the risk of prolonged discharge time or adverse effects.</p> Trial registration <p>The study was registered in the Chinese Clinical Trial Registry.&#xa0;(ChiCTR2400086957) on July 15, 2024.</p>

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Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial

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  • 发表日期：

    2025年7月29日

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  • Bao-Zhu Cha,
  • Shuang-Yan Hu,
  • Nian-Ping Chen,
  • Jia-Fei Cao,
  • Cheng Xu,
  • Kai Qiu,
  • Foquan Luo

摘要

Background

This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy.

Methods

Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety group (SAS < 50). All patients received intravenous administration of 5 µg/kg alfentanil combined with remimazolam besylate. The biased coin design up-and-down sequential method (BCD-UDM) was used to determine the target doses of remimazolam besylate: the initial dose was 0.1 mg/kg, with a dose gradient of 0.01 mg/kg. If coughing, swallowing, or body movement reactions occurred within the first 2 min from the start of gastroscopy, it was considered a positive reaction, and the dose was increased for the next patient. Otherwise, it was considered a negative reaction, and the dose of remimazolam besylate for the next patient was determined according to the BCD-UDM. Discharge time from the recovery room and adverse reactions were recorded. The ED50, ED90, and their 95% confidence intervals (CI) were calculated.

Results

The ED50 and ED90 of remimazolam besylate in the anxiety group were 0.175 mg/kg (95% CI, 0.140–0.240) and 0.251 mg/kg (95% CI, 0.173–0.250), respectively. In contrast, the ED50 and ED90 of remimazolam besylate in the non-anxiety group were 0.126 mg/kg (95% CI, 0.116–0.150) and 0.148 mg/kg (95% CI, 0.130–0.160), respectively. The ED90 equivalent ratio of the non-anxiety group to the anxiety group was 0.59 (95% CI, 0.468–0.710). The discharge time from the recovery room and the incidence of adverse reactions did not differ significantly between the groups.

Conclusions

When combined with 5 µg/kg alfentanil, the ED50 and ED90 of remimazolam besylate for inhibiting body movement response within two minutes of gastroscopy in anxious patients were 0.175 mg/kg and 0.251 mg/kg, respectively. Anxiety increased the requirement for remimazolam besylate in patients undergoing gastroscopy, but it did not increase the risk of prolonged discharge time or adverse effects.

Trial registration

The study was registered in the Chinese Clinical Trial Registry. (ChiCTR2400086957) on July 15, 2024.