Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
Summary
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults. Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research. Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals. Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2025-03-30
- Completion
- 2025-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remimazolam | Small molecule | 0.1 mg/kg | — |
| Subject | Remimazolam | Small molecule | 0.15 mg/kg | — |
| Subject | Remimazolam | Small molecule | 0.2 mg/kg | — |
Indications
No indication recorded.