A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

2022-08-2391

The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are: * Superiority of total procedure time in remimazolam compared to midazolam * The success of sedation time This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group

2023-05-01

2023-12-31

2023-12-31

Not yet recruiting

Early phase I

132

Inclusion Criteria: * Patients who agreed for this clinical trials * Patients who want diagnostic endoscopy under sedation * The total procedure time which is predicted within 15 minutes * ASA \>=2 * BMI more than 18.5kg/m2, less than 30kg/m2 Exclusion Criteria: * Patients who have stomach illness * Patients with respiratory disease * Mallampati Score\>=3 * Systolic BP \>160mmHg or \<90mmHg * Refractory Hypertension * Uncontrolled glaucoma * Severe liver failure or chronic kidney disease * Patients with drug abuse or alcohol abuse within 1 year * Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam) * Obstructive sleep dyspnea patients * Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Pregnant, breast feeding patient

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}

2023-05-01