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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| 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 | 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. |
| Related Links | https://bmcpulmmed.biomedcentral.com/counter/pdf/10.1186/s12890-024-03067-w.pdf |
| Ending Page | 6 |
| Page Count | 6 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14712466 |
| DOI | 10.1186/s12890-024-03067-w |
| Journal | BMC Pulmonary Medicine |
| Issue Number | 1 |
| Volume Number | 24 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2024-05-17 |
| Access Restriction | Open |
| Subject Keyword | Pneumology Respiratory System Internal Medicine Intensive Critical Care Medicine Sedation Remimazolam Endobronchial ultrasonography Protocol Pulmonary medicine Pneumology/Respiratory System |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pulmonary and Respiratory Medicine |
| Journal Impact Factor | 2.6/2023 |
| 5-Year Journal Impact Factor | 3/2023 |
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