Cited by 242Anesthesia and Sedative AgentsAnesthesia and Pain ManagementAnesthesia and Neurotoxicity Research

Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial

Doi, Matsuyuki, Hirata, Naoyuki, Suzuki, Toshiyasu, Morisaki, Hiroshi, Morimatsu, Hiroshi, Sakamoto, Atsuhiro·2020·Journal of Anesthesia

Abstract

Purpose Remimazolam, an ultra-short-acting benzodiazepine sedative is equally effective as propofol in induction and maintenance of general anesthesia with improved hemodynamic stability in American Society of Anesthesiologists (ASA) Class I and II patients. This trial investigated remimazolam's efficacy and safety in vulnerable patients (ASA Class III) undergoing elective general surgery. Methods A multicenter, randomized, double-blind, parallel-group trial in 67 adult surgical patients undergoing general anesthesia with two remimazolam induction doses (6 mg kg -1 h -1 -group A and 12 mg kg -1 h -1 -group B) has been conducted in 6 trials sites in Japan. Remimazolam was infused up to 2 mg kg -1 h -1 for maintenance of anesthesia in both groups. Results The functional anesthetic capability of the investigated drug was 100% in both arms. The mean time to loss of consciousness (LoC) was significantly shorter in group B (81.7 s) compared to group A (97.2 s), p = 0.0139. The mean bispectral index (BIS) value during maintenance of anesthesia ranged from 46.0 to 68.0 and from 44.7 to 67.5 in group A and B, respectively. There was no statistically significant difference between the remimazolam arms concerning the incidence of blood pressure (BP) decrease (67.7% in group B vs. 54.8% in group A), recovery profile or the incidence or severity of adverse events (AEs) or adverse drug reactions (ADRs). Conclusion Both induction regimens (6 and 12 mg kg -1 h -1 ) were equally efficacious a…

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Crossref · 10.1007/s00540-020-02776-w

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Authors
Doi, M., Hirata, N., Suzuki, T., Morisaki, H., Morimatsu, H., & Sakamoto, A.
Affiliations
  • Hamamatsu University Hospital (JP)
  • Sapporo Medical University (JP)
  • Tokai University (JP)
  • Keio University (JP)
  • Okayama University Hospital (JP)
  • Nippon Medical School (JP)
Corresponding author
Doi, Matsuyuki
Venue
Journal of Anesthesia
Published
2020-04-17
Volume
34
Issue
4
Pages
491-501
ISSN
  • 0913-8668 (ISSN-L)
  • 1438-8359
OpenAlex
W3016871582
Cited by
242
References
0
Citations by year
2026: 23 · 2025: 35 · 2024: 57 · 2023: 56 · 2022: 47 · 2021: 22 · 2020: 2
FWCI
37.12
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Anesthesia (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Anesthesia and Sedative Agents
  • Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
  • Life Sciences › Neuroscience › Developmental Neuroscience › Anesthesia and Neurotoxicity Research
Keywords
remimazolam, general anesthesia induction, anesthesia maintenance, high-risk surgical patients, ultra-short-acting benzodiazepine, hemodynamic stability, bispectral index, adverse drug reactions, recovery profiles
MeSH terms
Adult, Anesthesia, General, Benzodiazepines, Double-Blind Method, Humans, Hypnotics and Sedatives, Japan, Maintenance, Midazolam, Propofol

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