NCT06275594

Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

A Prospective, Open-label, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam in patienTs Undergoing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: REST Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Yeungnam University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2). Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure.

Conditions

• Midazolam
• Remimazolam

Interventions

Type	Name	Description
DRUG	Byfavo	For induction and maintenance of sedation
DRUG	Midazolam	For induction and maintenance of sedation

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: South Korea