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

Nanjing Medical University

Status and phase: Active, not recruiting; Phase 4

Conditions: Liver Failure; Intensive Care Unit; Mechanical Ventilation; Pharmacokinetics; Anesthesia

Treatments: Drug: Remimazolam 0.3mg/kg/h; Drug: Remimazolam 0.5mg/kg/h; Drug: Remimazolam 0.1mg/kg/h

Study type: Interventional

Funder types: Other

Identifiers

NCT05480787

2020120989remimazolam

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Remimazolam 0.1mg/kg/h

Experimental group

Description:

Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h.

Treatment:

Drug: Remimazolam 0.1mg/kg/h

Remimazolam 0.3mg/kg/h

Experimental group

Description:

Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h.

Treatment:

Drug: Remimazolam 0.3mg/kg/h

Remimazolam 0.5mg/kg/h

Experimental group

Description:

Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h.

Treatment:

Drug: Remimazolam 0.5mg/kg/h