AI Article Synopsis
- - The REST trial aims to assess the safety and effectiveness of remimazolam for moderate sedation during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), comparing it against standard midazolam treatments.
- - The study will enroll 330 patients with suspected lung cancer lesions across four university hospitals, randomly assigning them to receive either remimazolam or two types of midazolam for the procedure.
- - Through this trial, researchers hope to establish improved sedation practices for EBUS-TBNA, potentially enhancing patient experiences and outcomes.
Article 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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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11100028 | PMC |
| http://dx.doi.org/10.1186/s12890-024-03067-w | DOI Listing |
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