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

YUMC2023-12-017

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.

2024-03-01

2025-02-01

2025-02-01

Not yet recruiting

Early phase I

330

Inclusion Criteria: 1. Adult males and females aged 18 and above 2. ASA 1-3 3. BMI 18.5\~30.0 4. Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support 5. Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves Exclusion Criteria: 1. Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously 2. ASA 4 or higher 3. Mallampati score 4 4. BMI \< 18.5, BMI \>30.0 5. Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents 6. Bronchoscopy outside the bronchoscopy unit 7. chronic kidney disease on dialysis 8. Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease 9. Patients considered inappropriate for the study at the investigator's discretion

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 330, 'type': 'ESTIMATED'}}

2024-02-23