Comparison of Remimazolam Tosilate and Propofol Sedation on the Early Postoperative Quality of Recovery in Patients Undergoing Day Surgery: A Prospective Randomized Controlled Trial

Abstract

Purpose

Remimazolam tosilate is a novel ultrafast-acting benzodiazepine that has a rapid emergence even after continuous infusion when using flumazenil. So far, relatively few articles are still focusing on the quality of recovery after general anesthesia with remimazolam, especially in day surgery. This study aimed to compare the early postoperative quality of recovery of remimazolam tosilate with flumazenil and propofol in patients undergoing day surgery.

Patients and Methods

137 patients scheduled for day surgery were randomly divided into the remimazolam tosilate or propofol group. The primary endpoint was the incidence of overall recovery assessed with the early postoperative quality of recovery scale (PostopQRS) on postoperative day 1 (POD 1). The Richmond Agitation-Sedation Scale (RASS) scores in the post-anesthesia care unit (PACU), extubation time, postoperative recovery profiles, and perioperative data were documented. Any adverse events were recorded.

Results

The incidence of overall recovery on POD1 was 47.7% in the remimazolam tosilate group and 65.1% in the propofol group (odds ratio, 0.52; 95% confidence interval (CI) 0.26 to 1.06; P = 0.072). In general, the overall recovery of the PostopQRS increased over time, and its interaction between time and group was significant (P = 0.003). Among the five dimensions of PostopQRS, there exist statistical differences between groups including emotional state and cognitive recovery. Upon arrival at the PACU, the remimazolam group was more sedated and took longer to recover to a RASS score similar to propofol. The frequency of application of vasoactive drugs during anesthesia was similar in both groups (P = 0.119). Despite rapid emergence with remimazolam after flumazenil reversal, re-sedation (10.8%) or somnolence (60%) in the PACU was observed, and the length of PACU stay in patients treated with remimazolam tosilate was longer than that of the propofol (35 min vs 30 min, P<0.001).

Conclusion

General anesthesia with remimazolam tosilate in conjunction with flumazenil reversal permits rapid recovery of consciousness in day surgery, but there was a notable occurrence of re-sedation or somnolence observed in PACU.

Keywords:

• remimazolam tosilate
• flumazenil
• propofol
• day surgery
• quality of recovery

Abbreviations

PostopQRS, postoperative quality of recovery scale; POD, postoperative day; RASS, Richmond Agitation-Sedation Scale; PACU, post-anesthesia care unit; TIVA, total intravenous anesthesia; ASA, American Society of Anesthesiologists; BMI, body mass index; MMSE, Mini-Mental State Examination; CMMS, Chinese Mini-Mental Status; SpO₂, pulse oxygen saturation; NIBP, non-invasive blood pressure; TOF, train-of-four; BIS, bispectral index; MOAA/S, Modified Observer’s Assessment of Alertness/Sedation; GEE, generalized estimation equation; PONV, postoperative nausea and vomiting.

Data Sharing Statement

All data generated or analyzed during this study were included in the published article. Further inquiries about the datasets can be directed to the corresponding author upon reasonable request. An unauthorized version of the Chinese MMSE was used by the study team without permission. This issue was rectified between the authors and PAR. The MMSE is a copyrighted instrument and may not be used or reproduced in whole or in part, in any form or language, or by any means without written permission of PAR (www.parinc.com).

Acknowledgments

The authors would like to express gratitude to all of the staff who assisted in our research.

Disclosure

The authors declare no conflicts of interest in this study.