The effect of remimazolam on postoperative memory retention and delayed regeneration in breast surgery patients

Abstract

Background: Remimazolam, a benzodiazepine ultra-short-acting sedative, has been used in general anesthesia since August 2020. It is used in awake surgeries that require awakening the patient in the middle of the surgery because of its rapid awakening effect as well as antagonistic interactions. If remimazolam has associated anterograde amnesia similar to benzodiazepines, it will have a positive effect on preventing psychological trauma. However, to our knowledge, the effect of remimazolam on anterograde amnesia has not been previously examined. Methods/design: The aim of this exploratory, open, propofol-controlled, single-center, randomized clinical trial is to examine the effect of remimazolam on postoperative memory retention and delayed regeneration. Seventy patients undergoing breast surgery will be included in the study. The patients will be randomly assigned to receive propofol or remimazolam as sedatives during surgery. The primary endpoint is the number of posters patients remember 24 hours after surgery (among 4 posters shown after awakening from anesthesia) as an assessment of anterograde amnesia. Secondary endpoints are retrograde amnesia, dose of analgesic given from the time the patient returns to the ward until 24 hours after surgery, immediate postoperative pain numerical rating scale scores, and pain numerical rating scale scores 24 hours after leaving the operating room. Recruitment will take place between October 2021 and March 2022 to achieve the target sample size. Discussion: To our knowledge, this is the first trial designed to examine the effects of remimazolam on postoperative memory retention and delayed regeneration in patients undergoing breast surgery. Trial registration: This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center on September 28, 2021 (UMIN-CTR: UMIN000045593).

The Safety and Efficacy of Remimazolam Compared to Dexmedetomidine for Awake Tracheal Intubation by Flexible Bronchoscopy: A Randomized, Double-Blind, Controlled Trial

“…These results indicated that remimazolam had mild respiratory depression, minimal hemodynamic fluctuation, and no serious side effects, which were similar to the results of several previous clinical studies. [32][33][34] Our results confirmed that remimazolam, like other benzodiazepines, had an anterograde amnesia effect, [35][36][37] which was thought to be caused by the binding of remimazolam with the α1 of the GABAA receptor. 38 Although intubation comfort scores, cough scores, and post-intubation scores were not lower in group DS than that in groups R 1 S and R 2 S, patient satisfaction scores seemed to be higher in groups R 1 S and R 2 S than that in group DS due to the rates of amnesia for tracheal intubation being higher in groups R 1 S and R 2 S. A similar outcome was also seen in the study, 28 where the deeper, more consistent sedation and retrograde amnesia brought about by remimazolam resulted in median patient satisfaction scores that were higher in the remimazolam group than that in the dexmedetomidine group.…”

Recovery of memory retention after anesthesia with remimazolam: an exploratory, randomized, open, propofol-controlled, single-center clinical trial

“…An allocation supervisor appointed by the Data Center of the Clinical Research Promotion Department of the Clinical and Translational Center at our institution prepared an allocation table intended to avoid clinical involvement in the trial. The discontinuation criteria and the guidelines for monitoring adverse events have been described in detail in an earlier protocol [ 7 ].…”

Advances in The Assessment of the Sedative Effect of Remimazolam

“…Based on the premise that the BIS value of remimazolam is relatively high during general anesthesia, Dr. Kazuhiro Shirozu's team from Japan designed a single-arm clinical trial to compare the magnitude and correlation between BIS and PSI during general anesthesia with remimazolam [19]. The trial included 30 patients undergoing breast surgery under elective general anesthesia, and the results of the trial showed that the mean intraoperative BIS and PSI of all patients were 50.6±9.1 and 43.0±11.8, respectively, suggesting that the use of PSI to guide the intraoperative dosage of remimazolam might be more reliable.…”