Author:
Seol Hee Yun,Hong Kyung Soo,Jang Jong Geol,Moon Seong Mi,Kim Sun-Hyung,Cho Jun Yeun,Yang Bumhee,Kim Seonok,Choi Chang-Min,Ji Wonjun,Ahn June Hong
Abstract
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.
Funder
Korean Association for the Study of Targeted Therapy (KASTT) affiliated with Korean Association for Lung Cancer
Publisher
Springer Science and Business Media LLC