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

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Intensive Care Unit Mechanical Ventilation Anesthesia Liver Failure Pharmacokinetics

Interventions

Remimazolam 0.1mg/kg/hDRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.3mg/kg/hDRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.5mg/kg/hDRUG

Remimazolam Tosilate for Injection(36mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Plasma concentration of Remimazolam

Time frame: 24 hours

Secondary Outcomes

Adverse reactions

Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate

Time frame: 28 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes