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

Abstract

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.