Frontiers in medicine · 2025
The efficacy and safety of remimazolam for the management of emergence agitation: a randomized, double-blind, placebo-controlled study.
СтатьяНазвание и аннотация: Перевод в очереди
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Lu Xiaoxing, Zhou Meiyan, Lu Yao, Sun Jia, Mao Kexin, Zhu Yangzi, Wang Rongguo, Cao Yong, Wang Liwei
Аннотация
INTRODUCTION: 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.
METHODS: A total of 219 adults experienced EA (Riker Sedation-Agitation Scale SAS score ≥5) after otolaryngological surgery were randomly assigned (1:1:1 ratio) to receive one of the following three treatments: 2.5 mg remimazolam, 5.0 mg remimazolam, or placebo. The primary endpoint was the treatment success rate of EA, which was defined as an SAS score of <5 within 15 min after administration without the need for rescue sedation and no recurrence after 15 min. Secondary outcomes included rescue propofol dosage, EA duration, and the post-anesthesia care unit (PACU) discharge time. Adverse events were also monitored.
RESULTS: Both remimazolam groups (77.5% for 2.5 mg and 85.9% for 5.0 mg) had significantly higher treatment success rates compared to the placebo group (44.3%) (both p < 0.001). Additionally, they required less rescue propofol, had shorter EA durations, and faster PACU discharge times (all p < 0.001). Furthermore, the 2.5 mg 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) (p = 0.024 and 0.042, respectively). Exploratory analysis indicated that, for patients with dangerous agitation (SAS = 7), only the 5.0 mg group (83.3%) had a significantly higher treatment success rate than the placebo group (0%) (p < 0.001).
DISCUSSION: Our findings suggest that remimazolam is a promising option for managing EA in the PACU. For the entire study population, the 2.5 mg dose strikes an optimal balance between efficacy and safety. In patients with dangerous agitation, a 5.0 mg dose of remimazolam may offer potential benefits. These findings hold significant implications for guiding future therapeutic strategies for EA.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, identifier ChiCTR2400085903.
METHODS: A total of 219 adults experienced EA (Riker Sedation-Agitation Scale SAS score ≥5) after otolaryngological surgery were randomly assigned (1:1:1 ratio) to receive one of the following three treatments: 2.5 mg remimazolam, 5.0 mg remimazolam, or placebo. The primary endpoint was the treatment success rate of EA, which was defined as an SAS score of <5 within 15 min after administration without the need for rescue sedation and no recurrence after 15 min. Secondary outcomes included rescue propofol dosage, EA duration, and the post-anesthesia care unit (PACU) discharge time. Adverse events were also monitored.
RESULTS: Both remimazolam groups (77.5% for 2.5 mg and 85.9% for 5.0 mg) had significantly higher treatment success rates compared to the placebo group (44.3%) (both p < 0.001). Additionally, they required less rescue propofol, had shorter EA durations, and faster PACU discharge times (all p < 0.001). Furthermore, the 2.5 mg 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) (p = 0.024 and 0.042, respectively). Exploratory analysis indicated that, for patients with dangerous agitation (SAS = 7), only the 5.0 mg group (83.3%) had a significantly higher treatment success rate than the placebo group (0%) (p < 0.001).
DISCUSSION: Our findings suggest that remimazolam is a promising option for managing EA in the PACU. For the entire study population, the 2.5 mg dose strikes an optimal balance between efficacy and safety. In patients with dangerous agitation, a 5.0 mg dose of remimazolam may offer potential benefits. These findings hold significant implications for guiding future therapeutic strategies for EA.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, identifier ChiCTR2400085903.