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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05480787
• Other study ID #: 2020120989remimazolam
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours.

Exclusion Criteria:

Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Remimazolam 0.1mg/kg/h
Remimazolam Tosilate for Injection(36mg)
• Remimazolam 0.3mg/kg/h
Remimazolam Tosilate for Injection(36mg)
• Remimazolam 0.5mg/kg/h
Remimazolam Tosilate for Injection(36mg)

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of Remimazolam	Plasma concentration of Remimazolam	24 hours
Secondary	Adverse reactions	Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate	28 days