Efficacy of remimazolam versus midazolam for outpatient dental sedation: a multicenter, randomized, controlled, non-inferiority trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Purpose Intravenous sedation is commonly used in routine dental procedures, however, existing agents are associated with limitations in recovery profiles and postoperative complications. Remimazolam has emerged as a promising alternative to address these clinical challenges. This study aimed to establish the non-inferiority of titrated remimazolam compared to midazolam concerning both efficacy and safety endpoints in dental extraction procedures. Methods This randomized, single-blind, parallel-controlled, non-inferiority study was conducted across 13 centers in China from September 2021 to July 2023. A total of 612 eligible patients scheduled for dental extraction were randomized to receive either remimazolam (group R, initial dose of 0.1 mg/kg with 2 mg top-ups; n = 307) or midazolam (group M, initial dose of 0.05 mg/kg with 1 mg top-ups; n = 305). The primary endpoint was the sedation success rate, with a predefined non-inferiority margin of 6%. Secondary outcomes included recovery time, discharge readiness, adverse events, and 24-h postoperative complications. Results Remimazolam demonstrated non-inferior efficacy, achieving success rates of 99.0% compared to 96.1% for midazolam (adjusted risk difference, 95% confidence interval, 2.81 [−1.29 to 6.91]; adjusted P = 0.179). Patients in group R recovered faster and were discharged earlier than patients in group M (5 [3, 6] vs. 7 [4, 10] min, P < 0.001; and 46 [38, 53] vs. 52 [44, 60] min, P < 0.001). Additionally, patients in group R exhibited a significantly lower incidence of 24-h postoperative adverse reactions (4.6% vs. 12.1%; adjusted P = 0.030). Conclusions Titrated remimazolam demonstrates non-inferior sedation success when compared to midazolam while offering a superior recovery profile and improved postoperative safety. These findings indicate that remimazolam may serve as a more advantageous sedative option for outpatient dental procedures, especially in environments requiring rapid patient turnover. Trial registration The trial was registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2100050822, URL: https://www.chictr.org.cn/showproj.html?proj=133251 , Principal investigator: Hui Zhang, date of registration: September 4, 2021).
Authors: Bing Liu, Peijuan Wang, Wei Zhu, Cong Yu, Liyong Jia, Xiaotong Shi, Zhi Wang, Ting Xu, Qian Li, Xudong Yang, Juzhao Zhao, Zhoupeng Zheng, Yong Li, Na Xing, Tiejun Zhang, Nan Zhao, Weifang Shan, Qiumiao Chen, Lina Zhang, Yanyu Liu, Yuyan Sun, Zijian Guo, Qiuyuan Hong, Sulin Tang, Xiaofei Qi, Yanna Li, Li Wang, Zhaohua Ji, Rui Lu, Hui Zhang
Institutions: Air Force Medical University, Stomatological Hospital of Chongqing Medical University, Chongqing Medical University, Guangxi Medical University, Xi'an Jiaotong University, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Jinan Stomatological Hospital, Peking University, Peking University School and Hospital of Stomatology, Zhejiang University Medical College Affiliated Stomatological Hospital, Zhejiang University, Shenzhen Maternity and Child Healthcare Hospital, First Affiliated Hospital of Zhengzhou University, Wuhan University
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7128510525