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BMC Pulmonary Medicine

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

  • Open Access
  • 01-12-2024
  • Midazolam
  • Study Protocol
Published in:
Authors
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
Published in
BMC Pulmonary Medicine | Issue 1/2024

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.
Title
A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design
Authors
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
Publication date
01-12-2024
Publisher
BioMed Central
Published in
BMC Pulmonary Medicine / Issue 1/2024
Electronic ISSN: 1471-2466
DOI
https://doi.org/10.1186/s12890-024-03067-w
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