A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
NCT ID: NCT03921775
Last Updated: 2020-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2019-05-13
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group A
IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance
Remimazolam Tosilate
For induction and maintenance of general anesthesia
Treatment B
IV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance
Propofol
For induction and maintenance of general anesthesia
Interventions
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Remimazolam Tosilate
For induction and maintenance of general anesthesia
Propofol
For induction and maintenance of general anesthesia
Eligibility Criteria
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Exclusion Criteria
2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
4. Pregnant women or those in lactation period
5. Allergic to drugs used in the study
6. Patients with respiratory management difficulties (Modified Mallampati grade IV)
7. Patients have participated in other clinical trial within the 3 months prior to randomization
8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
18 Years
60 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HR-RMZL-Ⅲ-GA
Identifier Type: -
Identifier Source: org_study_id
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