NCT06153498

PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (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

Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.

Conditions

• Mechanically Ventilated Patients

Interventions

Type	Name	Description
DRUG	Remimazolam besylate	After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).

Timeline

• Start date: 2023-11-04
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-12-01
• Last updated: 2023-12-13

Locations

1 site across 1 country: China