Can Remimazolam Be a New Sedative Option for Outpatients Undergoing Ambulatory Oral and Maxillofacial Surgery?

Abstract

Midazolam is a classic sedative drug. The sedative effect of remimazolam has not been demonstrated in ambulatory oral and maxillofacial surgery (OMS). This study aimed to measure whether remimazolam can achieve the same sedation effects compared with midazolam, but with a faster recovery and fewer adverse reactions in outpatients undergoing ambulatory OMS. This was a prospective, randomized, controlled, single-center study of 40 patients who underwent ambulatory OMS at Peking University Hospital of Stomatology, Beijing, China, between April 2021 and June 2021. The patients were randomly divided into a midazolam group (Group M) and a remimazolam group (Group R). The success rate of sedation, which was defined as completion of the operation with no rescue sedative medication, was the primary outcome. In this study, bispectral index and modified observer's assessment of alertness/sedation value, intraoperative adverse events, time to discharge, and the number of additional doses of sedative were compared. Descriptive, comparative analyses were conducted. Forty patients were eligible for this study, and the final sample size was 40 (including 25 males, average age was 29). The success rate of sedation in Group R was statistically significantly higher than that in Group M (Group R vs Group M: 95% [19/20] vs 70% [14/20], P=.037, 95% confidence interval [CI]: 0.681 to 0.913). The median number of additional doses of the medications per 5minutes in Group R was lower than that in Group M (0.51 [0.19, 0.71] vs 0.82 [0.51, 1.25], P=.006, 95% CI: 0.013 to 0.583). Group R showed a higher bispectral index number (93.9±4.6 vs 86.6±7.2, P=.001, 95% CI: 3.451 to 11.149) at the end of the surgery and a higher modified observer's assessment of alertness/sedation score (4.70±0.47 vs 4.05±0.68, P=.001, 95% CI: 0.273 to 1.027) after 5minutes at the recovery room compared with Group M. The success rate of remimazolam is higher than that of midazolam. The use of remimazolam is effective for sedation of patients undergoing ambulatory OMS.