NCT06124404

Step 1 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 2
• Study type: Interventional
• Enrollment: 36 (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

This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.

Conditions

• Mechanically Ventilated Patients

Interventions

Type	Name	Description
DRUG	Remimazolam besylate	After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given
DRUG	Remimazolam besylate	After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given
DRUG	Remimazolam besylate	After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2023-11-09
• Last updated: 2026-03-19

Locations

1 site across 1 country: China