NCT05015361

A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation

Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.

Conditions

• Local Anesthesia Assisted Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam Tosilate	Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
DRUG	Propofol Injection.	Treatment group C: Propofol Injection.

Timeline

• Start date: 2021-05-07
• Primary completion: 2021-06-18
• Completion: 2021-07-04
• First posted: 2021-08-20
• Last updated: 2021-08-20

Locations

1 site across 1 country: China