A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
Phase 3
Completed
- Conditions
- Anesthesia for Elective Surgery Patients
- Interventions
- Registration Number
- NCT03921775
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A Remimazolam Tosilate IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance Treatment B Propofol IV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance
- Primary Outcome Measures
Name Time Method Percentage(%) of paticipants who experienced successful anesthesia during operation in each group Average of 2 hours
- Secondary Outcome Measures
Name Time Method Time from stop of investigational medicinal product to MOAA/S Score=5 Average of 2 hours Time from start of investigational medicinal product administration to loss of consciousness Average of 2 hours Time from stop of investigational medicinal product to Aldrete Score>9 Average of 2 hours
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China