Safety and effcacy of remimazolam tosilate for sedation during combined spinal-epidural anesthesia for orthopedic procedures: a randomized controlled trial

BMC Anesthesiol. 2024 Feb 26;24(1):75. doi: 10.1186/s12871-024-02451-7.

Abstract

Objective: The objective of this study was to assess the efficacy and safety of Remimazolam in the context of combined spinal-epidural anesthesia for sedation during orthopedic surgery.

Methods: This randomized controlled trial enrolled patients scheduled for orthopedic surgery under combined spinal-epidural anesthesia (N = 80), who were randomly allocated to receive either dexmedetomidine (Group-D) or remimazolam (Group-R). The target sedation range aimed for a Ramsay score of 2-5 or a BIS value of 60-80 to evaluate the effectiveness and safety of remimazolam during sedation.

Results: The time taken to achieve the desired level of sedation was significantly shorter in the remimazolam group compared to the dexmedetomidine group (3.69 ± 0.75 vs. 9.59 ± 1.03; P < 0.0001). Patients in the remimazolam group exhibited quicker recovery, fewer intraoperative adverse events, more consistent vital signs, and greater satisfaction at various time points throughout the surgery.

Conclusion: This preliminary study demonstrates that remimazolam tosilate serves as a safe and effective sedative for orthopedic surgery performed under combined spinal-epidural anesthesia, in comparison with dexmedetomidine.

Keywords: Dexmedetomidine; Ramsay; Remimazolam; Sedation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anesthesia, Epidural
  • Benzenesulfonates* / adverse effects
  • Benzodiazepines* / adverse effects
  • Dexmedetomidine / adverse effects
  • Humans
  • Hypnotics and Sedatives* / adverse effects
  • Orthopedic Procedures

Substances

  • 4-methylbenzenesulfonic acid
  • Benzenesulfonates
  • Benzodiazepines
  • Dexmedetomidine
  • Hypnotics and Sedatives
  • remimazolam