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

Abstract 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.