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Clinical trial

A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation

ID
Name
ARMS-
Description
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-06-30
Trial end
2023-06-30
Status
Not yet recruiting
Treatment
Remimazolam Tosilate for Injection
Remimazolam Tosilate for Injection
Arms:
Bronchoscopy sedation cohort, General anesthesia cohort
Size
1000
Primary endpoint
Adverse events
Within 3 days of receiving General anesthesia and bronchoscopy sedation
Eligibility criteria
Inclusion Criteria: 1. Patients using rebinim ® during general anesthesia and fiberoptic sedation 2. Patients need to sign informed consent Exclusion Criteria: 1. Patients who are participating in or planning to participate in any interventional clinical trial 2. The investigator considers that there are any other reasons for the patient's ineligibility for the study
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2022-09-22

1 organization

1 product

1 indication

Organization
Jiangsu HengRui Medicine
Product
Remimazolam Tosilate
Indication
Anesthesia and Sedation for Bronchoscopy