NCT05782894

Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Remimazolam besylate	0\~2.0mg/kg/h
DRUG	Propofol	0.3\~4.0mg/kg/h
DRUG	Remifentanil	1.5\~12μg/kg/h

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-11-25
• Completion: 2023-11-25
• First posted: 2023-03-24
• Last updated: 2024-01-31

Locations

1 site across 1 country: China