Comparison of remimazolam and sevoflurane for general anesthesia during transcatheter aortic valve implantation: a randomized trial

Abstract

Purpose: Safe perioperative management of patients undergoing transcatheter aortic valve implantation (TAVI) is crucial. Remimazolam is a newly developed short-acting benzodiazepine. We hypothesized that combining remimazolam and flumazenil would reduce emergence time compared with sevoflurane in patients undergoing general anesthesia for TAVI.

Methods: We conducted a prospective, randomized, parallel-design, open-label, single-centre clinical trial between June 2022 and August 2023 at Kagoshima University Hospital. We allocated patients randomly to either the remimazolam/flumazenil group or the sevoflurane group. Patients in the remimazolam group received iv remimazolam whereas patients in the sevoflurane group received sevoflurane for general anesthesia maintenance. Patients in both groups received a remifentanil infusion throughout the TAVI procedure (0.2 μg·kg^-1·min^-1 iv). Remimazolam and sevoflurane were adjusted to maintain a Bispectral Index™ (Covidien/Medtronic, Minneapolis, MN, USA) of 40-60. In the remimazolam group, flumazenil (0.2 mg iv) was administered immediately after remimazolam discontinuation. The primary outcome was time to extubation. Secondary outcomes included intraoperative variables (hemodynamic variables and vasopressor dose), rate of intra- and postoperative complications, and recovery of muscle strength.

Results: Overall, 60 patients were enrolled, and data from 56 were included. The median [interquartile range] time to extubation was significantly shorter in the remimazolam group than in the sevoflurane group (6.5 [5.1-8.1] min vs 14.2 [10.9-15.9] min; difference in medians, -6.9 min; 95% confidence interval, -8.7 to -5.0; P < 0.001). Statistically significant differences were observed in the perfusion index (P = 0.03) and regional cerebral oxygen saturation (P = 0.03) between the groups. No significant differences between the two groups were seen in other secondary outcomes.

Conclusions: Compared with sevoflurane, a combination of remimazolam and flumazenil significantly reduced the time to extubation in patients undergoing general anesthesia for TAVI. Therefore, remimazolam may be a suitable choice for general anesthesia in patients undergoing TAVI.

Study registration: UMIN.ac.jp ( UMIN000047892 ); first posted 30 May 2022.

Keywords: aortic stenosis; general anesthesia; remimazolam; sevoflurane; transcatheter aortic valve implantation.

Fig. 1

Flow diagram presenting patient selection and analysis. One patient in the sevoflurane group did not receive the intervention because of protocol violation (only verbal consent was obtained). We discontinued intervention in one patient in the sevoflurane group because of a protocol violation (another sedative was used). We excluded the postoperative data of two patients in the sevoflurane group because of loss to follow-up.

Fig. 2

Time course of hemodynamic variables. Boxes show medians (horizontal middle lines) and interquartile ranges (top and bottom parts of the boxes); whiskers show the lowest and highest values.