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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
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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“Compared with midazolam or propofol, numerous published clinical experiments have shown the safety and efficacy of remimazolam as an anesthetic during sedative procedures and general anesthesia (9,10).”
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Research works printed but not linked: 14
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“Remimazolam is widely recognized for its safety profile, particularly its hemodynamic stability [2,3].”
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“Propofol’s propensity to induce dose-dependent hypotension via sympathetic suppression and vasodilation contrasts with reduced remimazolam affinity for α 1-adrenergic receptors, suggesting less circulatory inhibition [ 34 , 35 ] .”
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Metadata
- 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
- ORCID
- 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 › Anesthesiology and Pain Medicine › 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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