The following is a summary of “A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design,” published in the May 2024 issue of Pulmonology by Seol et al.
Remimazolam has demonstrated safety and efficacy for moderate sedation during flexible bronchoscopy, yet its performance in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains uncertain. The REST trial (NCT06275594) aims to address this gap through a prospective, randomized study evaluating remimazolam’s role in patients undergoing EBUS-TBNA with conscious sedation. The primary objective is to assess the safety and efficacy of remimazolam compared to real-world midazolam and on-label midazolam.
The REST trial will enroll 330 patients across four university hospitals diagnosed with mediastinal lesions suspected of being lung cancer, eligible for EBUS-TBNA under moderate sedation. Participants will be randomly assigned to receive remimazolam, real-world midazolam, or on-label midazolam (following US prescribing information dosages) for procedural sedation during EBUS-TBNA. The primary endpoint will measure procedural success using composite criteria.
The REST trial aims to inform sedation practices and enhance patient outcomes during EBUS-TBNA under moderate sedation by prospectively evaluating remimazolam’s efficacy and safety. The findings are expected to contribute valuable insights into optimizing sedation strategies and improving clinical management for patients undergoing EBUS-TBNA.
Source: bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03067-w
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