Effect of Remimazolam Tosilate on Respiratory Depression in Elderly Patients Undergoing Gastroscopy: A Multicentered, Prospective, and Randomized Study

Drug Des Devel Ther. 2022 Dec 5:16:4151-4159. doi: 10.2147/DDDT.S391147. eCollection 2022.

Abstract

Background: Remimazolam tosilate (RT) is a new type of γ-aminobutyric acid subtype A (GABAA) receptor agonist, having the possibility to be an ideal sedative drug for procedural sedation. At present, there are few studies on the effect of RT on respiratory depression in elderly patients. We aimed to evaluate the effect of RT on respiratory depression in elderly patients undergoing gastroscopy.

Methods: This prospective, randomized, single-blinded trial recruited patients from eight centers in China between May 2022 and July 2022. A total of 346 elderly patients undergoing gastroscopy were randomly divided into RT group (0.2 mg/kg) or propofol group (1.5 mg/kg), respectively. The primary outcome was the incidence of respiratory depression. Secondary outcomes include the incidence of sedative-related adverse events, the success rate of sedation, time to fully alert, time to loss of consciousness (LOC), time to ready for discharge, as well as the the patients, endoscopists and anethetists' satisfaction.

Results: The incidence of respiratory depression was significantly reduced in the RT group compared with the propofol group (9.8% vs 17.9%, P=0.042). The time of LOC and fully alert in the RT group were longer than that in the propofol group (P < 0.05). The incidences of hypotention (50.9% vs 32.4%, P=0.001) and hypotension requiring treatment (5.8% vs 1.7%, P=0.031) were significantly higher in the propofol group than that in the RT group. The incidence and severity of injection pain were more frequently recorded in the propofol group than that in the RT group (40.5% vs 12.1%, P<0.05). There were no statistically significant differences between the two groups in terms of sedation success rates, time to ready for discharge, endoscopists and anethetists' satisfaction and other sedative-related adverse events.

Conclusion: RT may be a suitable alternative sedative agent for elderly patients undergoing gastroscopy due to its safety profile.

Keywords: Remimazolam tosilate; elderly patients; gastroscopy; propofol.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Gastroscopy
  • Humans
  • Hypnotics and Sedatives / adverse effects
  • Propofol* / adverse effects
  • Prospective Studies
  • Respiratory Insufficiency* / chemically induced
  • Respiratory Insufficiency* / diagnosis
  • Respiratory Insufficiency* / epidemiology

Substances

  • Propofol
  • Hypnotics and Sedatives

Grants and funding

This work was supported in part by grants from the Beijing Hongyi Medical Development Foundation (HY20210037-A-07), the Fund of Yunyan District Science and Technology department (yunkehezi[2021]10), Natural Science Foundation of China (No. 82160951, 82162024), the Science and Technology Fund of Guizhou Provincial Health Department (qiankehepingtairencai[2018]5779-52), the Fund of Guizhou Provincial Natural Science Foundation (qiankehejichu[2020]1Y298), the Cultivate project 2021 for National Natural Science Foundation of China, Affiliated Hospital of Guizhou Medical University (gyfynsfc-2021-35), the Fund of Guiyang Science and Technology department ([2019]9-1-24), the Health and Family Planning Commission of Guizhou Province (gzwkj2021-273), the Fund of Guizhou Provincial Education Department (qianjiaoheKYzi[2021]182).