CLINICAL TRIAL article
Front. Med.
Sec. Intensive Care Medicine and Anesthesiology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1489771
The ED50 and ED95 of remimazolam tosilate to inhibit the gastroscopy reaction in elderly patients of varying ages: an Up-and-Down Sequential Allocation Trial
Provisionally accepted
- 1Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang, China
- 2College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, China
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Objective: Although remimazolam tosilate (RT) has demonstrated efficacy in elderly gastroscopy, its optimum dose for gastroscopy in elderly patients of varying ages is still unclear. The study aimed to determine the median effective dose (ED50) and 95% effective dose (ED95) of RT to inhibit the gastroscopy reaction in patients aged 65-74 years and 75-89 years.Methods: Sixty-one elderly patients were randomized into two groups: Group A (65-74 years, n=31) and Group B (75-89 years, n=30). Three minutes after the recruited subjects received 0.1 μg/kg of sufentanil, RT was administered intravenously at an initial dose of 0.15 mg/kg with 0.01 mg/kg step size according to the modified Dixon's up-and-down method (UDM). This continued until nine crossover midpoints "positive-negative" were observed.The ED50 of RT calculated by the modified UDM for inhibiting the gastroscopy reaction in Group A (0.175 (95% confidence interval, CI, 0.166-0.183) mg/kg) was higher than that in Group B (0.163 (95% CI, 0.156-0.169) mg/kg) (P=0.03). The ED95 estimated by probit regression analysis was 0.199 (95% CI, 0.186-0.244) mg/kg in Group A and 0.188 (95% CI, 0.175-0.232) mg/kg in Group B.RT is a relatively safe sedative hypnotic that can provide a suitable sedative effect for elderly patients undergoing a gastroscopy. Clinical Trial Registration: Registered at Chinese Clinical Trial Registry (ChiCTR2200062842, http://www.chictr.org.cn).
Keywords: Remimazolam, Elderly, Gastroscopy, geriatric, effective dose, Up-and-down method
Received: 24 Oct 2024; Accepted: 09 Apr 2025.
Copyright: © 2025 Yang, Xiong, Xu, Wu, Chen, Jiang and Zou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xiaohua Zou, Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.