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Comparison of 95% effective dose of Remimazolam and Propofol for gastroscopy sedation on elderly patients: a single-center randomized controlled trial
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  • Enci Ye,
  • Keyang Wu,
  • Hui Ye,
  • Wenyuan Zhang,
  • Lihua Chu,
  • Kai Zhang,
  • Guohao Xie,
  • Yue Jin,
  • Xiangming Fang
Enci Ye
Zhejiang University School of Medicine First Affiliated Hospital
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Keyang Wu
Zhejiang University School of Medicine First Affiliated Hospital
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Hui Ye
Zhejiang University School of Medicine First Affiliated Hospital
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Wenyuan Zhang
Zhejiang University School of Medicine First Affiliated Hospital
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Lihua Chu
Zhejiang University School of Medicine First Affiliated Hospital
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Kai Zhang
Zhejiang University School of Medicine First Affiliated Hospital
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Guohao Xie
Zhejiang University School of Medicine First Affiliated Hospital
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Yue Jin
Zhejiang University School of Medicine First Affiliated Hospital
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Xiangming Fang
Zhejiang University School of Medicine First Affiliated Hospital
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Abstract

Aim: Advanced age is an important risk factor for adverse events during procedural sedation. Remimazolam is safe and effective in adults’ gastroscopy sedation. The ideal dose and availability for elderly patients are not well known. We aim to investigate its 95% effective dose (ED95) for elderly patients undergoing gastroscopy, and to assess its safety and efficacy, with propofol as the comparison. Methods: The trial consists of two parts, patients who are over 65 and scheduled for elective outpatient painless gastroscopy were enrolled. In the first part, Dixon’s up-and-down methodology was used to determine the ED95 of remimazolam and propofol for inhibiting body movement during gastroscopic insertion, in combination with 0.2μg/kg remifentanil. In the second part, patients in each group received 0.2μg/kg remifentanil and the ED95 dose of the study drug for sedation induction, adding supplemental doses to maintain sedation depth when necessary. The primary outcome was the incidence of adverse events. The secondary outcome was the recovery time. Results: The ED95 of remimazolam and propofol induction dose were 0.204mg/kg [95% CI (0.175–0.390) mg/kg] and 1.994 mg/kg [95% CI (1. 739–5.955) mg/kg] respectively in gastroscopy. Adverse events were reported in 40.6% of patients in the remimazolam group and 83.1% in the propofol group (p<0.001), whereas the remimazolam group showed a higher incidence of hiccup(p=0.017). A shorter time to awakening (p<0.05) in the remimazolam group was observed. Conclusion: For elderly patients undergoing gastroscopy, the ED95 dose of remimazolam is a safer alternative than propofol when inducing the same sedation depth.
29 Jul 2022Submitted to British Journal of Clinical Pharmacology
01 Aug 2022Assigned to Editor
01 Aug 2022Submission Checks Completed
05 Aug 2022Reviewer(s) Assigned
28 Sep 2022Review(s) Completed, Editorial Evaluation Pending