Efficacy and Safety of Remimazolam, a Novel Benzodiazepine, in Upper and Lower Endoscopy

Aims Remimazolam, an ultra-short-acting benzodiazepine, was introduced as a sedative for general anesthesia in August 2020. Remimazolam has the following characteristics: little circulatory and respiratory depression, a very short half-life of less than 40 minutes, and being antagonized by flumazenil as well as midazolam. Because of these remarkable features, it has attracted attention as a novel benzodiazepine sedative with relatively high safety and good adjustability. Until now, Midazolam, which has been used mainly as a sedative for endoscopic procedure, has a longer half-life than flumazenil, and thus has the risk of re-sedation, where the patient is awakened by flumazenil and then re-sedated. The risk of re-sedation caused to longer recovery observation time and a subsequent reduction in the number of procedures. On the other hand, Remimazolam, which has a shorter half-life than flumazenil, has almost no risk of re-sedation. It was considered that Remimazolam had several advantages in terms of patient safety, shorter recovery observation time and increasing the number of procedures. However, in Japan, it is currently not approved by insurance as a sedative for endoscopic procedures, and its use is limited to off-label use. Therefore, there is insufficient evidence for its efficacy and safety. In our hospital, we have been using Remimazolam as a sedative for endoscopy after obtaining permission for off-label use from the ethics committee and consent from the patients. Based on our experience, we report on the efficacy and safety of Remimazolam.

Methods We retrospectively evaluated pre and post operative endoscopy with Remimazolam from January 2024 to February 2024. A total of 233 esophagogastroduodenoscopy (EGD) and 38 colonoscopy (CS) were included. The outcomes are patient background, procedure time, need for antagonist, and adverse events such as circulatory and respiratory depression.

Results The median examination time was 22 minutes for EGD and 33 minutes for CS. Antagonism with flumazenil was required in 24 cases (10.3%) in EGD and 5 cases (13.2%) in CS, fluid supply was required in 18 cases (7.7%) in EGD and 2 cases (5.3%) in CS due to decreased blood pressure, oxygen administration was required in 36 cases (15.4%) in EGD and 1 case (2.6%) in CS due to respiratory depression. Although blood pressure was significantly lower in post-procedure compared to pre-procedure, the median post-procedure blood pressure was not critical, 121 mmHg in EGD and 120 mmHg in CS. There was no significant decrease in SpO₂ for either EGD and CS. A few percent of patients complained of discomfort or poor awaking after procedures in either EGD and CS. No case required urgent treatment by rapid response team.

Conclusions Remimazolam could be an effective and safe sedative for EGD and CS.

 

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Conflicts of Interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
27 March 2025