Remimazolam besylate in intravenous conscious sedation for dental treatment: a prospective cohort study

Introduction This study aimed to assess the efficacy and safety of remimazolam for dental intravenous conscious sedation. It focused on evaluating sedation success rate, management of pre-operative anxiety, sedation depth, psychomotor recovery and variations in vital parameters. Materials and methods This single-centre, prospective cohort study involved 101 patients undergoing dental procedures. Sedation was administered according to the European Medicines Agency guidelines, and outcomes were assessed by: sedation success rates; anxiety reduction, as measured by the Visual Analogue Scale for Anxiety (VAS-A); depth of sedation, as assessed by the Ramsay Sedation Scale; psychomotor recovery, as assessed by the Newman test; and physiologic stability, defined as meeting Post-Anaesthetic Discharge Scoring System criteria. Results Remimazolam achieved an 100% procedural success rate without rescue sedatives. Pre-operative anxiety (mean MDAS: 16.87 ± 4.80; mean VAS-A: 7.07) was effectively managed, with 69% of patients reporting high or very high anxiolytic effects. Vital parameters remained stable, with variations consistently <20% from baseline values. Psychomotor recovery was rapid, with a mean recovery time of 49 minutes, and most patients were discharged within 60-90 minutes. Most patients (65%) experienced anterograde amnesia, while 74% described their preferred experience during the procedure as ‘sleep' and 26% as ‘calmness'. Minimal adverse effects were reported, and patient satisfaction scores were high (mean VAS satisfaction: 9.73). Conclusions Remimazolam demonstrated excellent efficacy, safety and patient satisfaction in dental procedural sedation. Its rapid recovery profile, minimal cardiovascular and respiratory impact, and effective anxiolytic properties establish it as a reliable alternative to midazolam, particularly for moderate- to high-risk patients. These findings support the integration of remimazolam into outpatient dental care, with the potential for broader application in paediatric and disabled populations.