Evaluation of the Safety and Efficacy of Remimazolam Combined With Remifentanil for Sedation in Adult Dental Anxiety Patients Undergoing Mandibular Impacted Third Molar Extraction: A Single-Center, Retrospective Cohort Analysis.

Abstract

Aims/Background Dental anxiety (DA) often leads to significant fear and anxiety in the patients undergoing dental procedures, and increases the complexity and difficulty of treatment. Currently, remimazolam, a benzodiazepine-like sedative drug, has been found effective and safe during endoscopic and surgical procedures. Therefore, this study aimed to evaluate the safety levels and efficacy profile of remimazolam combined with remifentanil for sedation in adult patients with DA who underwent the mandibular impacted third molar extraction. Methods This single-center, retrospective cohort study included adult patients with DA who underwent mandibular impacted third molar extraction at the Beijing Stomatological Hospital between January 2021 and December 2023. Based on the sedation protocols used during dental procedures, patients were divided into two groups: a remimazolam combined with remifentanil group (the remimazolam group, n = 63) and a propofol combined with remifentanil group (the propofol group, n = 71). The overall incidence of adverse events was selected as the primary outcome measure, including pulse oxygen saturation (SpO₂) <93%, injection pain, sedation failure, hypotension, bradycardia, and nausea/vomiting. The secondary outcome measures included sedation onset time, postoperative pain levels, satisfactions of patient and anesthesiologists, and vital signs changes over time. Results The remimazolam group showed an overall incidence of adverse events of 7.9%, compared to 49.3% in the propofol group, with a statistically significant difference between the two groups (p < 0.001). Both study groups demonstrated no statistically significant differences in sedation onset time (p = 0.252) and postoperative pain Verbal Rating Scale (VRS) score (p = 0.527). Moreover, the remimazolam group had greater stability in blood pressure (between-group effect, p = 0.012) and heart rate (between-group effect, p < 0.001) and exhibited statistically significant differences in changes in respiratory rate over time (between-group effect, p < 0.001). Anesthesiologists' satisfaction scores with respiratory and circulatory stability, sedation efficacy, and quality of sedation recovery were significantly higher in the remimazolam group compared to the propofol group (p < 0.001). Surgeons reported a higher satisfaction with sedation efficacy in the remimazolam group. Conclusion In summary, remimazolam combined with remifentanil demonstrates greater safety and effectiveness than propofol combined with remifentanil for sedation during dental procedures in adult DA patients. This combination particularly decreases adverse events, maintains stable respiratory and circulatory functions, and improves satisfaction levels among anesthesiologists and surgeons.