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

BMC Pulm Med. 2024 May 17;24(1):243. doi: 10.1186/s12890-024-03067-w.

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.

Keywords: Endobronchial ultrasonography; Protocol; Pulmonary medicine; Remimazolam; Sedation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Benzodiazepines
  • Bronchoscopy / adverse effects
  • Bronchoscopy / methods
  • Conscious Sedation* / methods
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration* / adverse effects
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration* / methods
  • Female
  • Humans
  • Hypnotics and Sedatives* / administration & dosage
  • Lung Neoplasms* / drug therapy
  • Lung Neoplasms* / pathology
  • Male
  • Midazolam* / administration & dosage
  • Middle Aged
  • Prospective Studies
  • Randomized Controlled Trials as Topic

Substances

  • Benzodiazepines
  • Hypnotics and Sedatives
  • Midazolam
  • remimazolam

Associated data

  • ClinicalTrials.gov/NCT06275594