Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
NCT05782894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2024-01-31
Summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
Conditions
- Sedative
- Mechanical Ventilation
Interventions
- DRUG
-
Remimazolam besylate
0\~2.0mg/kg/h
- DRUG
-
Propofol
0.3\~4.0mg/kg/h
- DRUG
-
Remifentanil
1.5\~12μg/kg/h
Sponsors & Collaborators
-
Yichang Humanwell Pharmaceutical Co., Ltd., China
collaborator INDUSTRY -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-28
- Primary Completion
- 2023-11-25
- Completion
- 2023-11-25
Countries
- China
Study Locations
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