NCT05480787

Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU

Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.

Conditions

• Intensive Care Unit
• Mechanical Ventilation
• Anesthesia
• Liver Failure
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Remimazolam 0.1mg/kg/h	Remimazolam Tosilate for Injection(36mg)
DRUG	Remimazolam 0.3mg/kg/h	Remimazolam Tosilate for Injection(36mg)
DRUG	Remimazolam 0.5mg/kg/h	Remimazolam Tosilate for Injection(36mg)

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-08-15
• Completion: 2022-09-01
• First posted: 2022-07-29
• Last updated: 2022-07-29

Locations

1 site across 1 country: China