A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
- Conditions
- Gastroscopic and Colonoscopic Sedation
- Interventions
- Registration Number
- NCT05254366
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
- Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
- Patients need to sign informed consent
Exclusion Criteria
- Patients who are participating in or planning to participate in any interventional clinical trial
- The investigator considers that there are any other reasons for the patient's ineligibility for the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Remimazolam Tosilate for Injection Painless gastroscopic sedation cohort Cohort 2 Remimazolam Tosilate for Injection Painless colonoscopy sedation cohort
- Primary Outcome Measures
Name Time Method Adverse events Within 3 days of receiving gastroscopy and colonoscopy Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
- Secondary Outcome Measures
Name Time Method Serious adverse events Within 3 days of receiving gastroscopy and colonoscopy Refer to SAE definition standards
Adverse drug reactions Within 3 days of receiving gastroscopy and colonoscopy By evaluating the association of adverse events with drugs
Injection pain questionnaire Within 3 days of receiving gastroscopy and colonoscopy By observing and asking