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

Phase 4

• Conditions: Anesthesia; Liver Failure; Mechanical Ventilation; Pharmacokinetics; Intensive Care Unit
• Interventions: Drug: Remimazolam 0.1mg/kg/h; Drug: Remimazolam 0.3mg/kg/h; Drug: Remimazolam 0.5mg/kg/h

• Registration Number: NCT05480787
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2022-08-15
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam 0.1mg/kg/h	Remimazolam 0.1mg/kg/h	Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h.
Remimazolam 0.3mg/kg/h	Remimazolam 0.3mg/kg/h	Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h.
Remimazolam 0.5mg/kg/h	Remimazolam 0.5mg/kg/h	Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h.

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Remimazolam	24 hours	Plasma concentration of Remimazolam

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	28 days	Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China