Comparison of the recovery profile of remimazolam with flumazenil and propofol anesthesia for open thyroidectomy

Abstract

Background: Previous studies have consistently reported a slower recovery of consciousness following remimazolam-based total intravenous anesthesia without flumazenil than with propofol. This study aimed to compare the reversal effect of flumazenil on the recovery of consciousness after remimazolam-based total intravenous anesthesia with the propofol recovery profile.

Methods: This prospective, single-blinded, randomized trial included 57 patients undergoing elective open thyroidectomy at a tertiary university hospital. Patients were randomly allocated to receive either remimazolam- or propofol-based total intravenous anesthesia (remimazolam group: 28 patients, propofol group: 29 patients). The primary outcome was the time from the end of general anesthesia to first eye opening (min). The secondary outcomes were the time from the end of the general anesthesia to extubation (min), initial modified Aldrete score measured at the post-anesthesia care unit, length of stay at the post-anesthesia care unit (min), occurrence of postoperative nausea and vomiting during the first 24 h postoperatively, and Korean version of Quality of Recovery-15 score at 24 h postoperatively.

Results: The remimazolam group showed significantly faster first eye opening time (2.3 [interquartile range, IQR: 1.8-3.3] min vs. 5.0 [IQR: 3.5-7.8] min, median difference:-2.7 [95% confidence interval, CI: -3.7 to -1.5] min, P < 0.001) and extubation time (3.2 [IQR: 2.4-4.2] min vs. 5.7 [IQR: 4.7-8.3] min, median difference: -2.7 [97.5% CI: -5.0 to -1.6] min, P < 0.001). There were no significant differences in other postoperative outcomes.

Conclusions: The planned incorporation of flumazenil with remimazolam-based total intravenous anesthesia provided rapid and reliable recovery of consciousness.

Trial registration: ClinicalTrials.gov NCT05047939.

Keywords: Benzodiazepines; Delayed emergence from anesthesia; Flumazenil; General anesthetics; Intravenous anesthesia.

Fig. 1

CONSORT diagram of patient recruitment

Fig. 2

Between group comparisons of the time from the end of the general anesthesia to first eye opening (A) and extubation (B). The box plot shows the median and interquartile range of time in the remimazolam (n = 28) and propofol (n = 29) groups. Upper and lower whiskers are maximum and minimum values excluding outliers, respectively. The scatter plot (round symbols) shows the individual data points. The violin plot shows the distribution of the data points for each group. The width of each violin represents the density of the data points. ^**Adjusted P < 0.01, ^***Adjusted P < 0.001