NCT06222294

A Study of Remimazolam Tosilate for Sedation in the ICU

A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (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 sedation 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
DRUG	Propofol Medium and Long Chain Fat Emulsion Injection	Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h

Timeline

• Start date: 2024-03-12
• Primary completion: 2024-08-13
• Completion: 2024-09-24
• First posted: 2024-01-24
• Last updated: 2026-01-09

Locations

1 site across 1 country: China