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

Drug Des Devel Ther. 2024 May 23:18:1743-1754. doi: 10.2147/DDDT.S456675. eCollection 2024.

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: day surgery; flumazenil; propofol; quality of recovery; remimazolam tosilate.

Publication types

  • Randomized Controlled Trial
  • Comparative Study
  • Case Reports
  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Ambulatory Surgical Procedures
  • Anesthesia Recovery Period
  • Benzodiazepines* / administration & dosage
  • Female
  • Flumazenil / administration & dosage
  • Flumazenil / pharmacology
  • Flumazenil / therapeutic use
  • Humans
  • Hypnotics and Sedatives* / administration & dosage
  • Hypnotics and Sedatives* / pharmacology
  • Male
  • Middle Aged
  • Propofol* / administration & dosage
  • Prospective Studies

Substances

  • Propofol
  • Benzodiazepines
  • remimazolam
  • Hypnotics and Sedatives
  • Flumazenil