Efficacy and safety of remimazolam tosilate in anesthesia for short otolaryngology surgery.

Autor: Cheng W; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China., Cheng Y; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China., He H; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China., Zhou D; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China., Wang J; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China., Zhang Y; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China. zyzy@zmu.edu.cn., Wang Z; Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China. zy2ane@126.com.
Jazyk: angličtina
Zdroj: BMC anesthesiology [BMC Anesthesiol] 2024 Nov 11; Vol. 24 (1), pp. 407. Date of Electronic Publication: 2024 Nov 11.
DOI: 10.1186/s12871-024-02790-5
Abstrakt: Background: Remimazolam tosilate represents the novel ultrashort-acting benzodiazepine drug. This work focused on exploring whether remimazolam tosilate was effective and safe in anesthesia for short otolaryngology surgery in adults, and optimize its medication regimen, thus providing a theoretical basis for its widespread clinical application.
Methods: The present unicentric, double-blind, randomized controlled study enrolled altogether 85 otolaryngology surgery patients aged 18-60 years, and they were divided as remimazolam (RM, 42 cases) or midazolam (MD, 43 cases) group. Efficacy outcomes included successful sedation time, sedation effect (Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score), bispectral index values (BIS), and postoperative recovery. The safety outcomes were patient vital signs at each time point (before induction (T0), 2 min and 5 min after trial drug treatment (T1 and T2 separately), during successful intubation (T3), at the end of surgery (T4), during extubation (T5), and at the time of exiting the room (T6)), any adverse reactions (AEs) during perioperative period, and patient satisfaction with anesthesia experience.
Results: Demographics were not significantly different in both groups (P > 0.05). RM group had significantly decreased successful sedation time relative to MD group (P < 0.05), while increased successful sedation rate (100%) relative to MD group (90.70%, P = 0.116). RM group showed decreased MOAA/S score and BIS value compared with MD group at T1 and T2 (P < 0.05). The spontaneous respiration recovery time and extubation time were not significantly different in both groups (P > 0.05), but RM group exhibited decreased discharge time compared with MD group (P < 0.05). Compared with MD group, the RM group had lower blood pressure (BP) at T3 (P < 0.05); whereas higher heart rate (HR) and respiration rate (RR) at T1 and T2 (P < 0.05). Difference in AEs was not of statistical significance. Finally, RM group exhibited the increased satisfaction of anesthesia experience compared with MD group (P < 0.05).
Conclusion: Remimazolam tosilate is effective on anesthesia for short otolaryngology surgery. Remimazolam shows the rapid onset, stable circulation, fast postoperative recovery, no increase in perioperative AEs, and high satisfaction with anesthesia experience compared with midazolam.
Trial Registration: https://www.chictr.org.cn/ (ChiCTR2200067123) on 27/12/2022. This study was consistent with CONSORT guidelines.
Competing Interests: Declarations Ethics approval and consent to participate This study was permitted by the medical ethics review committee of the Second Affiliated Hospital of Zunyi Medical University (NO. KYLL-2022-027) and registered in the Chinese Clinical Trial Registry (ChiCTR2200067123). Every patient or the legal representative provided informed consent prior to performing these procedures. This study was performed in accordance with the CONSORT criteria and Declaration of Helsinki. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Figures’ authenticity The figures presented are plotted by our authors, who verify the image originality without any duplication or previous publication.
(© 2024. The Author(s).)
Databáze: MEDLINE
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