B80-4-47 Efficacy and Safety of Remimazolam for Moderate Sedation During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Multicenter, Randomized, Open-label Trial (REST Trial)

Background

Effective sedation is essential to ensure procedural stability and patient safety during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). While remimazolam has demonstrated safety and efficacy for moderate sedation during flexible bronchoscopy, its clinical performance specifically during EBUS-TBNA remains to be fully established. We evaluated the efficacy and safety of remimazolam compared to two midazolam strategies—real-world dosing (higher dose) and on-label dosing (standard dose)—for moderate sedation during EBUS-TBNA.

Methods

The REST trial (NCT06275594) was a prospective, multicenter, open-label, randomized controlled trial. Adults undergoing EBUS-TBNA were randomized 1:1:1 to remimazolam (Remi), real-world midazolam (RW-Mida), or on-label midazolam (OL-Mida), with fentanyl co-administration according to the protocol. The primary endpoint was procedural success, defined as a composite of procedure completion, no requirement for rescue sedation, and no excess top-up doses. Secondary outcomes included time from first dose to procedure start (sedation onset), total procedure duration, time to full alertness, post-procedural antagonist use, and safety outcomes.

Results

A total of 163 patients were included in the final analysis (Remi: n = 56, RW-Mida: n = 54, OL-Mida: n = 53). The procedural success rate was significantly higher in the Remi (94.6%) and RW-Mida (83.3%) groups compared to the OL-Mida group (64.2%, p < 0.001, Table 1). In subgroup analyses compared with OL-Mida, both RW-Mida and Remimazolam demonstrated superior efficacy in patients aged ≥60 years, males, all BMI categories, and ASA class I-II. Notably, only remimazolam maintained a significant benefit in female patients, whereas RW-Mida did not. Regarding procedural efficiency, the time to procedure start was significantly shorter in the Remi group (3.18 ± 2.02 min) compared to the OL-Mida group (6.34 ± 2.68 min, p < 0.001). Kaplan-Meier analysis revealed that more than 90% of patients in the Remi group achieved adequate sedation to start the procedure within 5 minutes. No statistically significant differences were observed in total procedure duration (p = 0.997), time to full alertness (p = 0.423), or post-procedural antagonist use (p = 0.321) among the three groups. Safety profiles, including the incidence of hypotension and hypoxia, were comparable across all groups.

Conclusions

Remimazolam demonstrated superior procedural success and faster sedation onset compared to on-label midazolam, while achieving success rates comparable to real-world midazolam practice without compromising safety. These findings support remimazolam as a highly efficient and safe option for moderate sedation during EBUS-TBNA.

This abstract is funded by: This research was supported by Korean Association for the Study of Targeted Therapy (KASTT) affiliated with Korean Association for Lung Cancer (KASTT 20230211 to JH Ahn).