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

NCT05480787 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-29

No results posted yet for this study

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.

Conditions

  • Intensive Care Unit
  • Mechanical Ventilation
  • Anesthesia
  • Liver Failure
  • Pharmacokinetics

Interventions

DRUG

Remimazolam 0.1mg/kg/h

Remimazolam Tosilate for Injection(36mg)

DRUG

Remimazolam 0.3mg/kg/h

Remimazolam Tosilate for Injection(36mg)

DRUG

Remimazolam 0.5mg/kg/h

Remimazolam Tosilate for Injection(36mg)

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-08-15
Completion
2022-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480787 on ClinicalTrials.gov