NCT05913336

A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Conditions

• Sedation in the ICU

Interventions

Type	Name	Description
DRUG	Remimazolam Tosilate	Loading dose: 0.08mg/kg , Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h

Timeline

• Start date: 2023-06-27
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2023-06-22
• Last updated: 2025-09-03

Locations

1 site across 1 country: China