{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T19:53:02Z","timestamp":1783799582233,"version":"3.55.0"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T00:00:00Z","timestamp":1755561600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Emergence agitation (EA) is a common postoperative complication characterized by confusion, disorientation, and restless behavior that can lead to self-harm, the removal of medical devices, and other adverse events. This randomized, double-blind, placebo-controlled study was designed to assess the efficacy and safety of a novel benzodiazepine, remimazolam, in the management of EA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 219 adults experienced EA (Riker Sedation-Agitation Scale SAS score \u22655) after otolaryngological surgery were randomly assigned (1:1:1 ratio) to receive one of the following three treatments: 2.5\u202fmg remimazolam, 5.0\u202fmg remimazolam, or placebo. The primary endpoint was the treatment success rate of EA, which was defined as an SAS score of &amp;lt;5 within 15\u202fmin after administration without the need for rescue sedation and no recurrence after 15\u202fmin. Secondary outcomes included rescue propofol dosage, EA duration, and the post-anesthesia care unit (PACU) discharge time. Adverse events were also monitored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Both remimazolam groups (77.5% for 2.5\u202fmg and 85.9% for 5.0\u202fmg) had significantly higher treatment success rates compared to the placebo group (44.3%) (both <jats:italic>p<\/jats:italic> &amp;lt;\u202f0.001). Additionally, they required less rescue propofol, had shorter EA durations, and faster PACU discharge times (all <jats:italic>p<\/jats:italic> &amp;lt;\u202f0.001). Furthermore, the 2.5\u202fmg group showed a lower incidence of hypoxia (7.0%) and hypotension (14.1%) compared to the placebo group (22.9% for hypoxia, 31.4% for hypotension) (<jats:italic>p<\/jats:italic> =\u202f0.024 and 0.042, respectively). Exploratory analysis indicated that, for patients with dangerous agitation (SAS\u202f=\u202f7), only the 5.0\u202fmg group (83.3%) had a significantly higher treatment success rate than the placebo group (0%) (<jats:italic>p<\/jats:italic> &amp;lt;\u202f0.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Our findings suggest that remimazolam is a promising option for managing EA in the PACU. For the entire study population, the 2.5\u202fmg dose strikes an optimal balance between efficacy and safety. In patients with dangerous agitation, a 5.0\u202fmg dose of remimazolam may offer potential benefits. These findings hold significant implications for guiding future therapeutic strategies for EA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p><jats:uri>https:\/\/www.chictr.org.cn\/<\/jats:uri>, identifier ChiCTR2400085903.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2025.1612779","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T05:20:09Z","timestamp":1755580809000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["The efficacy and safety of remimazolam for the management of emergence agitation: a randomized, double-blind, placebo-controlled study"],"prefix":"10.3389","volume":"12","author":[{"given":"Xiaoxing","family":"Lu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meiyan","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yao","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kexin","family":"Mao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangzi","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongguo","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong","family":"Cao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liwei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,8,19]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"471","DOI":"10.4097\/kja.20097","article-title":"Emergence 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