Anesthesia, Intensive Care Unit, Liver Failure, Mechanical Ventilation, Pharmacokinetics
Conditions
Keywords
Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics
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.
Interventions
DRUGRemimazolam 0.1mg/kg/h
Remimazolam Tosilate for Injection(36mg)
DRUGRemimazolam 0.3mg/kg/h
Remimazolam Tosilate for Injection(36mg)
DRUGRemimazolam 0.5mg/kg/h
Remimazolam Tosilate for Injection(36mg)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Remimazolam | 24 hours | Plasma concentration of Remimazolam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 28 days | Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate |
Countries
China
Outcome results
None listed