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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
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
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 240 |
| Start date | 2024-01 |
| Completion | 2024-03 |
Conditions
- Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Interventions
- Remimazolam Tosilate for Injection
- Remimazolam Tosilate for Injection
Primary outcomes
- Rate of sedation success, Sedation success — day 1
Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.
Countries
China