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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

Corresponding Author:[email protected]

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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 2022Submission Checks Completed
01 Aug 2022Assigned to Editor
05 Aug 2022Reviewer(s) Assigned
28 Sep 2022Review(s) Completed, Editorial Evaluation Pending
15 Oct 2022Editorial Decision: Revise Major
07 Nov 20221st Revision Received
08 Nov 2022Submission Checks Completed
08 Nov 2022Assigned to Editor
08 Nov 2022Review(s) Completed, Editorial Evaluation Pending
19 Nov 2022Reviewer(s) Assigned
26 Dec 2022Editorial Decision: Revise Minor
02 Jan 20232nd Revision Received
02 Jan 2023Submission Checks Completed
02 Jan 2023Assigned to Editor
02 Jan 2023Review(s) Completed, Editorial Evaluation Pending
11 Mar 2023Editorial Decision: Revise Major
02 Apr 20233rd Revision Received
03 Apr 2023Submission Checks Completed
03 Apr 2023Assigned to Editor
03 Apr 2023Review(s) Completed, Editorial Evaluation Pending
23 Apr 2023Editorial Decision: Revise Major
27 Apr 20234th Revision Received
27 Apr 2023Submission Checks Completed
27 Apr 2023Assigned to Editor
27 Apr 2023Review(s) Completed, Editorial Evaluation Pending
30 May 2023Editorial Decision: Revise Minor
31 May 20235th Revision Received
31 May 2023Submission Checks Completed
31 May 2023Assigned to Editor
31 May 2023Review(s) Completed, Editorial Evaluation Pending
24 Jun 2023Editorial Decision: Accept