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Adverse Drug Events Observed with the Newly Approved Remimazolam in Comparison to Propofol for General Anesthesia in Patients Undergoing Surgery: A Meta-analysis

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Abstract

Introduction

Developments in anesthetic pharmacology have been aiming at minimizing physiological disturbance in addition to maintaining and improving titrateability, recovery profile, and patient experience. Remimazolam, a GABAAlpha receptor agonist, is a new intravenous anesthetic agent which has recently been approved for use. This analysis aimed to systematically compare the adverse drug events reported with the newly approved remimazolam in comparison to propofol for general anesthesia (GA) in patients undergoing surgery.

Methods

Electronic databases were searched from 15 May to 20 December 2023 for relevant publications which compared the outcomes reported with the newly approved remimazolam versus propofol in patients undergoing surgery. Relevant reported adverse drug events were the endpoints of this study. The statistical analysis was carried out using the latest version of the RevMan software. Data analysis was represented by risk ratio (RR) with 95% confidence intervals (CI).

Results

Sixteen studies with a total number of 1897 participants were included in this analysis; 1104 participants received remimazolam and 793 participants received propofol. The risks for hypotension (RR 0.50, 95% CI 0.43–0.58; P = 0.00001), hypoxemia (RR 0.43, 95% CI 0.19–0.99; P = 0.05), bradycardia (RR 0.53, 95% CI 0.36–0.78; P = 0.001), pain at injection site (RR 0.07, 95% CI 0.01–0.56; P = 0.01), and total adverse events (RR 0.33, 95% CI 0.24–0.47; P = 0.00001) were significantly lower with remimazolam. However, no significant differences were observed in terms of postoperative nausea and vomiting (RR 0.98, 95% CI 0.66–1.46; P = 0.93), dizziness (RR 0.42, 95% CI 0.11–1.57; P = 0.20), psychiatric symptoms (RR 1.09, 95% CI 0.45–2.67; P = 0.85), and respiratory depression (RR 0.81, 95% CI 0.24–2.76; P = 0.74).

Conclusion

Our current analysis showed that the newly approved remimazolam was apparently associated with significantly fewer adverse drug events in comparison to propofol for GA in patients undergoing surgery. Therefore, this new drug should be further studied and more research with larger population sizes should be carried out to confirm this hypothesis.

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Data Availability

All data generated or analyzed during this study are included in this published article. Furthermore, the data are available in all online databases including MEDLINE, EMBASE, Web of Science, and so on. References have been provided throughout the manuscript.

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Acknowledgements

We would like to thank the participants of this study.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Funding

No funding or sponsorship was received for this study or publication of this article.

Author information

Author notes

  1. Lidan Huang and Hong Liu contributed equally to this work and they are both first authors of this paper.

Authors and Affiliations

  1. Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, People’s Republic of China

    Lidan Huang

  2. Department of Anesthesiology, Sichuan Mianyang 404 Hospital, Mianyang, 621100, Sichuan, People’s Republic of China

    Hong Liu

  3. Department of Anesthesiology, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, 434020, Hubei, People’s Republic of China

    Xue Zou

  4. Department of Cardiology, Beijing Chaoyang Hospital, Beijing, 100012, Chaoyang, People’s Republic of China

    Jiawang Ding

  5. Department of Pain Therapy, Huzhou Traditional Chinese Medicine Hospital, Zhejiang Chinese Medicinal University, Huzhou, 313000, Zhejiang, People’s Republic of China

    Song Tao

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  1. Lidan Huang
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Contributions

The authors Lidan Huang, Hong Liu, Xue Zou, Jiawang Ding, and Song Tao were responsible for the conception and design, as well as drafting the manuscript at its initial stage and revising it critically for important intellectual content. Lidan Huang and Hong Liu wrote the final draft. Approval was given by all the authors for submission and publication of this manuscript.

Corresponding author

Correspondence to Song Tao.

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Conflict of Interest

The authors Lidan Huang, Hong Liu, Xue Zou, Jiawang Ding, and Song Tao declare that they have no potential conflicts of interest.

Ethical Approval

This meta-analysis is based on previously published studies and does not contain any studies with human participants or animals performed by any of the authors. Therefore, no ethical approval was required for this meta-analysis.

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Huang, L., Liu, H., Zou, X. et al. Adverse Drug Events Observed with the Newly Approved Remimazolam in Comparison to Propofol for General Anesthesia in Patients Undergoing Surgery: A Meta-analysis. Adv Ther 41, 1896–1910 (2024). https://doi.org/10.1007/s12325-024-02820-1

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