NCT05539521

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• 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

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

Detailed description

This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Conditions

• Critically Ill
• Deep Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam Besylate	sedation drugs
DRUG	Propofol	Propofol

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-02-01
• Completion: 2023-03-01
• First posted: 2022-09-14
• Last updated: 2022-09-26

Locations

1 site across 1 country: China