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Background <p>This randomized controlled trial aimed to compare the respiratory safety profiles of remimazolam versus propofol during non-intubated general anesthesia.</p> Methods <p>This single-center, randomized controlled trial investigated 200 female patients undergoing Open Excision of Benign Breast Nodule (OEBN) under non-intubated general anesthesia. Participants were randomly assigned to receive either remimazolam or propofol for anesthesia induction and maintenance, combined with remifentanil. We employed the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale for continuous sedation monitoring. The primary endpoint was the incidence of respiratory depression. Secondary outcomes encompassed: postoperative recovery quality, sedation success rate, frequency of respiratory depression episodes, requirement for airway interventions, and occurrence of adverse events (including hemodynamic instability and procedure-related complications).</p> Results <p>Of 200 randomized participants, 173 completed all study procedures and were included in the final analysis (Group R: <i>n</i> = 87; Group P: <i>n</i> = 86). The remimazolam group exhibited superior respiratory safety profiles compared to the propofol group, with a lower incidence of respiratory depression (89.7% vs 97.7%, <i>p</i> = 0.031) and a significantly reduced requirement for airway interventions (all <i>p</i> &lt; 0.05). Furthermore, remimazolam predominantly induces mild respiratory depression (73.6%), whereas propofol is more frequently associated with severe respiratory suppression (44.2%). Regarding adverse events, Group R demonstrated markedly lower rates of injection pain (0% vs 39.5%, <i>p</i> &lt; 0.001), hypotension (29.9% vs 46.5%, <i>p</i> = 0.024), and bradycardia (18.4% vs 44.2%, <i>p</i> &lt; 0.001). Patients receiving remimazolam (Group R) demonstrated significantly superior hemodynamic stability compared to the propofol group.</p> Conclusion <p>Although both remimazolam and propofol demonstrated a high incidence of respiratory depression, remimazolam was associated with milder respiratory suppression and a reduced need for airway interventions during OEBN with non-intubated general anesthesia. Additionally, it offers better hemodynamic stability and fewer adverse events, making it a safer alternative for such procedures.</p> Clinical trial registration <p>ChiCTR2400089826.</p>

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The effect of remimazolam versus propofol on respiratory depression for non-intubated general anesthesia: a randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月31日

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  • Yutao Chen,
  • Siru Li,
  • Di Wang,
  • Wenhui Zhang,
  • Chenxin Jiang,
  • Naying Su,
  • Congjie Bi

摘要

Background

This randomized controlled trial aimed to compare the respiratory safety profiles of remimazolam versus propofol during non-intubated general anesthesia.

Methods

This single-center, randomized controlled trial investigated 200 female patients undergoing Open Excision of Benign Breast Nodule (OEBN) under non-intubated general anesthesia. Participants were randomly assigned to receive either remimazolam or propofol for anesthesia induction and maintenance, combined with remifentanil. We employed the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale for continuous sedation monitoring. The primary endpoint was the incidence of respiratory depression. Secondary outcomes encompassed: postoperative recovery quality, sedation success rate, frequency of respiratory depression episodes, requirement for airway interventions, and occurrence of adverse events (including hemodynamic instability and procedure-related complications).

Results

Of 200 randomized participants, 173 completed all study procedures and were included in the final analysis (Group R: n = 87; Group P: n = 86). The remimazolam group exhibited superior respiratory safety profiles compared to the propofol group, with a lower incidence of respiratory depression (89.7% vs 97.7%, p = 0.031) and a significantly reduced requirement for airway interventions (all p < 0.05). Furthermore, remimazolam predominantly induces mild respiratory depression (73.6%), whereas propofol is more frequently associated with severe respiratory suppression (44.2%). Regarding adverse events, Group R demonstrated markedly lower rates of injection pain (0% vs 39.5%, p < 0.001), hypotension (29.9% vs 46.5%, p = 0.024), and bradycardia (18.4% vs 44.2%, p < 0.001). Patients receiving remimazolam (Group R) demonstrated significantly superior hemodynamic stability compared to the propofol group.

Conclusion

Although both remimazolam and propofol demonstrated a high incidence of respiratory depression, remimazolam was associated with milder respiratory suppression and a reduced need for airway interventions during OEBN with non-intubated general anesthesia. Additionally, it offers better hemodynamic stability and fewer adverse events, making it a safer alternative for such procedures.

Clinical trial registration

ChiCTR2400089826.