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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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