BMC Pulmonary Medicine (May 2024)

A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design

  • Hee Yun Seol,
  • Kyung Soo Hong,
  • Jong Geol Jang,
  • Seong Mi Moon,
  • Sun-Hyung Kim,
  • Jun Yeun Cho,
  • Bumhee Yang,
  • Seonok Kim,
  • Chang-Min Choi,
  • Wonjun Ji,
  • June Hong Ahn

DOI
https://doi.org/10.1186/s12890-024-03067-w
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 6

Abstract

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Abstract Background Remimazolam is safe and effective for moderate sedation during flexible bronchoscopy, but its safety and efficacy during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains undetermined. The REST trial (NCT06275594) will be a prospective randomized study of remimazolam in patients undergoing EBUS-TBNA with conscious sedation. The primary aim is to evaluate whether remimazolam is safe and effective for moderate sedation during EBUS-TBNA compared to real-world midazolam and on-label midazolam. Methods The REST trial will recruit 330 patients from four university hospitals with mediastinal lesions suspected of being lung cancer who are eligible for EBUS-TBNA under moderate sedation. The participants will be randomized into groups using remimazolam, real-world midazolam, and on-label midazolam (US prescribing information dosage) to perform EBUS-TBNA for procedural sedation. The primary endpoint will be procedural success using composite measures. Discussion The REST trial will prospectively evaluate the efficacy and safety of remimazolam during EBUS-TBNA under moderate sedation. It will provide information for optimizing sedation modalities and contribute to practical benefits in patients undergoing EBUS-TBNA. Trial registration ClinicalTrials.gov (NCT06275594). Prospectively registered on 15 February 2024.

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