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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Failure; Pharmacokinetics; Anesthesia; Intensive Care Unit; Mechanical Ventilation
• Intervention / Treatment: Drug: Remimazolam 0.1mg/kg/h; Drug: Remimazolam 0.3mg/kg/h; Drug: Remimazolam 0.5mg/kg/h

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 225500
      • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Remimazolam 0.1mg/kg/h; Remimazolam Tosilate for Injection(36mg)
EXPERIMENTAL: 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.	Drug: Remimazolam 0.3mg/kg/h; Remimazolam Tosilate for Injection(36mg)
EXPERIMENTAL: 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.	Drug: Remimazolam 0.5mg/kg/h; Remimazolam Tosilate for Injection(36mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of Remimazolam	Plasma concentration of Remimazolam	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate	28 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): August 15, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (ACTUAL): July 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Intensive Care Unit; Sedation; Anesthesia; Mechanical Ventilation; Remimazolam; Liver Failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: 2020120989remimazolam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No