Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Ne… (NCT06275594) | Clinical Trial Compass
UnknownPhase 2
Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
South Korea330 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult males and females aged 18 and above
✓. ASA 1-3
✓. BMI 18.5\~30.0
✓. Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support
✓. Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves