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Cited by 42Anesthesia and Sedative AgentsAirway Management and Intubation TechniquesVeterinary Pharmacology and Anesthesia

Effect of remimazolam tosilate on the incidence of hypoxemia in elderly patients undergoing gastrointestinal endoscopy: A bi-center, prospective, randomized controlled study

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Liu, Fang, Cheng, Xiaoyan, Wang, Yingjie, Li, Kai, Peng, Tianliang, Fang, Ningning, Pasunooti, Kalyan K., Jun, Seungho +2 more·2023·Frontiers in Pharmacology
DOI 10.3389/fphar.2023.1131391PMC PMC10151819
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Abstract

Background: Remimazolam tosilate is a new ultra-short-acting benzodiazepine sedative medicine. In this study, we evaluated the effect of remimazolam tosilate on the incidence of hypoxemia during sedation in elderly patients undergoing gastrointestinal endoscopy. Methods: Patients in the remimazolam group received an initial dose of 0.1 mg/kg and a bolus dose of 2.5 mg of remimazolam tosilate, whereas patients in the propofol group received an initial dose of 1.5 mg/kg and a bolus dose of 0.5 mg/kg of propofol. Patients received ASA standard monitoring (heart-rate, non-invasive blood pressure, and pulse oxygen saturation) during the entire examination process. The primary outcome was the incidence of moderate hypoxemia (defined as 85%≤ SpO 2< 90%, >15s) during the gastrointestinal endoscopy. The secondary outcomes included the incidence of mild hypoxemia (defined as SpO 2 90%–94%) and severe hypoxemia (defined as SpO 2< 85%, >15s), the lowest pulse oxygen saturation, airway maneuvers used to correct hypoxemia, patient’s hemodynamic as well as other adverse events. Results: 107 elderly patients (67.6 ± 5.7 years old) in the remimazolam group and 109 elderly patients (67.5 ± 4.9 years old) in the propofol group were analyzed. The incidence of moderate hypoxemia was 2.8% in the remimazolam group and 17.4% in the propofol group (relative risk [RR] = 0.161; 95% confidence interval [CI], 0.049 to 0.528; p < 0.001). The frequency of mild hypoxemia was less in the remimazolam group, but not statistically significant (9.3% vs. 14.7%; RR = 0.637; 95% CI, 0.303 to 1.339; p = 0.228). There was no significant difference in the incidence of severe hypoxemia between the two groups (4.7% vs. 5.5%; RR = 0.849; 95% CI, 0.267 to 2.698; p = 0.781). The median lowest SpO 2 during the examination was 98% (IQR, 96.0%–99.0%) in patients in the remimazolam group, which was significantly higher than in patients in the propofol group (96%, IQR, 92.0%–99.0%, p < 0.001). Patients in the remimazolam group received more drug supplementation during endoscopy than patients in the propofol group (p = 0.014). There was a statistically significant difference in the incidence of hypotension between the two groups (2.8% vs. 12.8%; RR = 0.218; 95% CI, 0.065 to 0.738; p = 0.006). No significant differences were found in the incidence of adverse events such as nausea and vomiting, dizziness, and prolonged sedation. Conclusion: This study explored the safety of remimazolam compared with propofol during gastrointestinal endoscopy in elderly patients. Despite the increased supplemental doses during sedation, remimazolam improved risk of moderate hypoxemia (i.e., 85%≤ SpO 2 < 90%) and hypotension in elderly patients.

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  • Only two RCTs had some concerns regarding deviations from the intended intervention.

    “Only two RCTs 40,42 had some concerns regarding deviations from the intended intervention.”

    From Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis. (2024) · cites this paper as [42]

    Section 2.3 (Randomization and blinding) identifies this study as a randomized trial and says the anesthetists knew treatment assignments. The Discussion acknowledges that this may have introduced bias. The paper does not assess deviations from the intended intervention or establish that only two RCTs had concerns; those are assessments made across trials by the citing authors. (LLM, conf=0.78)

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Cited by

Sorted by citations

Authors
Liu, F., Cheng, X., Wang, Y., Li, K., Peng, T., Fang, N., Pasunooti, K. K., Jun, S., Yang, X., & Wu, J.
Affiliations
  • Shandong University (CN)
  • Weifang Medical University (CN)
  • Qilu Hospital of Shandong University (CN)
  • Johns Hopkins University (US)
Corresponding author
  • Yang, Xiaomei
  • Wu, Jianbo
ORCID
Venue
Frontiers in Pharmacology
Publisher
Frontiers Media SA
Published
2023-04-18
Volume
14
Pages
1131391-1131391
ISSN
1663-9812 (ISSN-L)
DOI
10.3389/fphar.2023.1131391
PMC
PMC10151819
OpenAlex
W4366290780
Cited by
42
References
1
Citations by year
2026: 8 · 2025: 16 · 2024: 16 · 2023: 2
FWCI
13.80
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Pharmacology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • DR-NTU (Nanyang Technological University) (submittedVersion, cc-by)
Funders
  • Shandong University
  • Qilu Hospital of Shandong University
  • National Natural Science Foundation of China
  • China Postdoctoral Science Foundation (2021M691944)
  • Natural Science Foundation of Shandong Province
Topics
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Anesthesia and Sedative Agents
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Airway Management and Intubation Techniques
  • Health Sciences › Veterinary › Small Animals › Veterinary Pharmacology and Anesthesia
Keywords
remimazolam tosilate, propofol, procedural sedation, hypoxemia, gastrointestinal endoscopy, elderly patients, oxygen saturation, hemodynamic stability, adverse events, airway management, sedation safety, procedural sedation and analgesia, endoscopic sedation

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