A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

HR7056-401

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures

2024-01-01

2024-03-01

2024-03-01

Not yet recruiting

Early phase I

240

Inclusion Criteria: 1. Age ≥18 years old, male or female 2. Intending to undergo routine gastroscopy or colonoscopy 3. ASA (American Society of Anesthesiologists) I to III 4. 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2 5. Signed informed consent Exclusion Criteria: 1. Subjects need to be tracheal intubation 2. Subjects need to be complicated endoscopic diagnostic and therapeutic procedures 3. Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF 4. Heart rate \<50 beats/min during the screening period 5. Poor blood pressure control during the screening period 6. Subjects with severe respiratory diseases 7. Subjects with respiratory management difficulties (Modified Mallampati grade IV) 8. Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment 9. A history of drug abuse or addiction within 2 years prior to signing the ICF 10. Pregnant women or those in lactation period 11. Allergic to relevant drugs ingredient or component in the study 12. Currently participating in or planning to participate in other drug or device clinical trials during this study 13. Other conditions deemed unsuitable to be included

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-01-22