Abstract
PURPOSE: Remimazolam is an ultrashort-acting benzodiazepine, which has been indicated to be effective in endoscopic surgery and general anaesthesia. Research on its use in outpatient dental procedures remains limited. This triple-blinded randomized clinical trial was designed to determine whether the quality of postoperative recovery is better with continuous intravenous remimazolam administration compared with midazolam administration for impacted wisdom tooth extraction in patients with dental anxiety. PATIENTS AND METHODS: This study was a randomized, parallel triple-blinded, superiority trial conducted between 30 April 2022 and 24 June 2024. Participants aged ≥18 years who exhibited dental anxiety and who were eligible for impacted wisdom tooth extraction in an outpatient setting were included in this study. Participants were randomly assigned at a 1:1 ratio to receive either a continuous intravenous infusion of remimazolam or midazolam. The primary outcome was the time to recover full alertness. The secondary outcome was postoperative anterograde amnesia. RESULTS: A total of 150 participants were randomized in this study, with 75 patients assigned to the remimazolam group and 75 patients assigned to the midazolam group. The time to complete alertness was significantly shorter in the remimazolam group than in the midazolam group (3.0 ± 3.6 min vs 4.7 ± 5.2 min, mean difference, -1.9 min; 95% CI, -3.3min to -0.4 min; P = 0.013). The odds of immediate and delayed anterograde amnesia were much reduced with remimazolam administration compared with midazolam administration (immediate: 0.14, 95% CI, 0.05 to 0.34, delayed: 0.07, 95% CI, 0.03 to 0.15, both P < 0.001). CONCLUSION: For patients with dental anxiety, remimazolam offers not only faster recovery, but also a much better restoration of memory function compared with midazolam. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05350085.