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Purpose <p>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.</p> Methods <p>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&#xa0;mg/kg with 2&#xa0;mg top-ups; n = 307) or midazolam (group M, initial dose of 0.05&#xa0;mg/kg with 1&#xa0;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.</p> Results <p>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 <i>P</i> = 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, <i>P</i> &lt; 0.001; and 46 [38, 53] vs. 52 [44, 60] min, <i>P</i> &lt; 0.001). Additionally, patients in group R exhibited a significantly lower incidence of 24-h postoperative adverse reactions (4.6% vs. 12.1%; adjusted <i>P</i> = 0.030).</p> Conclusions <p>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.</p> Trial registration <p>The trial was registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2100050822, URL: <a href="https://www.chictr.org.cn/showproj.html?proj=133251">https://www.chictr.org.cn/showproj.html?proj=133251</a>, Principal investigator: Hui Zhang, date of registration: September 4, 2021).</p>

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Efficacy of remimazolam versus midazolam for outpatient dental sedation: a multicenter, randomized, controlled, non-inferiority trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月10日

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  • 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

摘要

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).