Remimazolam 50mg powder for solution for injection vials

Background Remimazolam is a novel sedative drug approved for procedural sedation and general anesthesia. Clinical trials have already explored its use in elderly patients for general anesthesia. For elderly patients with declining physical and physiological function, anesthesia safety is crucial. Most current clinical studies compare the safety of remimazolam and propofol, though the results are inconsistent. Therefore, we conducted a meta-analysis to compare the safety of remimazolam and propofol in general anesthesia for elderly patients. Methods We systematically searched the PubMed, Cochrane Library, Embase, and Web of Science databases for all published randomized controlled trials comparing remimazolam and propofol for general anesthesia in elderly patients. We synthesized data from eligible studies using relative risk or mean difference, and analyzed differences in hemodynamic stability and adverse effects between the two drugs. Data extraction and quality assessment were performed independently by two researchers. Results Eight randomized controlled trials involving 571 participants were included. Compared to propofol, remimazolam was associated with a lower incidence of hypotension (RR = 0.51, 95% CI: [0.33, 0.81], I2 = 18%, p = 0.3 > 0.1) and bradycardia (RR = 0.56, 95% CI: [0.31, 1.02], Z = 1.88, p = 0.06  0.05), but this result was not statistically significant. Among other secondary outcomes, the remimazolam group had lower incidences of injection site pain, nausea and vomiting, and hypoxemia compared to the propofol group, and also had a shorter extubation time. Conclusion In this meta-analysis, compared to propofol, remimazolam reduced the incidence of hypotension, bradycardia, and injection site pain during general anesthesia in elderly patients. The mean arterial pressure (MAP) and heart rate (HR) were more stable after induction. Remimazolam may be a safer sedative for elderly patients. Systematic review registration https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024516950, CRD42024516950.

Abstract licence: CC BY

Background and Objectives: Remimazolam, a novel benzodiazepine, is used for procedural sedation and general anesthesia due to its rapid onset and short duration of action. However, remimazolam-induced anaphylaxis (RIA) is a rare but severe complication. This study aimed to analyze RIA characteristics, focusing on cardiovascular collapse, and provide guidelines for safe remimazolam use. Methods: This study conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Research articles retrieved from PubMed on 26 May 2023, using the keywords ‘remimazolam AND anaphylaxis’ were evaluated based on the inclusion criteria of being written in English and aligning with the World Allergy Organization criteria for anaphylaxis, while studies not meeting these criteria were excluded. All published articles up to the search date were included without any date restrictions. The review analyzed factors such as age, sex, type of anesthesia, remimazolam dose (bolus/continuous), allergic symptoms and sign, epinephrine use, serum tryptase levels, and skin prick tests. Results: Among eleven cases, the mean age was 55.6 ± 19.6 years, with 81.8% male. Hypotension (81.8%) was the most common symptom, followed by bradycardia (54.5%) and desaturation (36.4%). Two patients experienced cardiac arrest. Serum tryptase levels confirmed anaphylaxis in ten cases. Epinephrine was the primary treatment, with intravenous doses ranging from 0.1 mg to 0.3 mg. Conclusions: Vigilance is crucial when administering remimazolam, adhering to recommended dosages, and promptly treating RIA with epinephrine. Further research is needed to understand the risk factors and refine the management strategies. Guidelines for safe remimazolam use are proposed.

Abstract licence: CC BY 4.0

Background Remimazolam is an ultra-short-acting benzodiazepine with sedative effects, but its impact on postoperative delirium (POD) and cognitive function in elderly patients remains unclear. This study aimed to compare the incidence of POD and cognitive function between remimazolam and other sedatives in elderly patients undergoing general anesthesia or procedural sedation. Methods This study included randomized controlled trials (RCTs) comparing remimazolam with other sedatives in elderly patients undergoing general anesthesia or procedural sedation. A comprehensive search was conducted in Ovid MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and the China National Knowledge Infrastructure (CNKI) from inception to January 2, 2025, without language restrictions. Data were pooled quantitatively using a random-effects model. The primary outcomes were the incidence of POD and cognitive function. Results A total of 1,808 elderly patients from 11 RCTs were included. Compared with other sedatives, remimazolam did not increase the incidence of POD (OR: 0.62, 95% CI [0.23, 1.68], p = 0.35, I2 = 73%), but improve cognitive function, as measured by Mini-Mental State Examination scores, the seventh postoperative day (MD: 0.53, 95% CI [0.16, 0.91], p = 0.005, I2 = 28). Additionally, remimazolam significantly reduced the incidence of hypotension (OR: 0.27, 95% CI [0.21, 0.35], p < 0.001, I2 = 0%) and respiratory depression (OR: 0.35, 95% CI [0.17, 0.69], p = 0.003, I2 = 0%) compared to other sedatives. However, no significant differences were observed between remimazolam and other sedatives for postoperative nausea and vomiting (OR: 1.31, 95% CI [0.91, 1.89], p = 0.15, I2 = 0%) or hypoxemia (OR: 0.69, 95% CI [0.35, 1.34], p = 0.28, I2 = 0%). Conclusion Overall, the use of remimazolam in the elderly population appears to pose fewer risks than other sedatives. It does not increase the incidence of postoperative delirium following general anesthesia or sedation, but it improves postoperative cognitive function and provides more stable hemodynamics. However, further well-designed RCTs with long-term follow-up are needed to establish a standardized medication regimen and optimal dosage tailored to elderly patients. Systematic review registration https://www.crd.york.ac.uk/PROSPERO/myprospero, registration number (CRD4202563620).

Abstract licence: CC BY