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

NCT ID: NCT05480787

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intensive Care Unit Mechanical Ventilation Anesthesia Liver Failure Pharmacokinetics

Keywords

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Remimazolam Intensive Care Unit Mechanical Ventilation Anesthesia Sedation Liver Failure Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Remimazolam 0.1mg/kg/h

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

Group Type EXPERIMENTAL

Remimazolam 0.1mg/kg/h

Intervention Type DRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.3mg/kg/h

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

Group Type EXPERIMENTAL

Remimazolam 0.3mg/kg/h

Intervention Type DRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.5mg/kg/h

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

Group Type EXPERIMENTAL

Remimazolam 0.5mg/kg/h

Intervention Type DRUG

Remimazolam Tosilate for Injection(36mg)

Interventions

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Remimazolam 0.1mg/kg/h

Remimazolam Tosilate for Injection(36mg)

Intervention Type DRUG

Remimazolam 0.3mg/kg/h

Remimazolam Tosilate for Injection(36mg)

Intervention Type DRUG

Remimazolam 0.5mg/kg/h

Remimazolam Tosilate for Injection(36mg)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Hu J, Zhao Y, Shao L, Zhang W, Wang H, Liu Y, Su M, Zuo X. Pharmacokinetic Properties and Therapeutic Effectiveness of Remimazolam in ICU Patients With Mechanical Ventilation: A Preliminary Study. Pharmacol Res Perspect. 2025 Jun;13(3):e70130. doi: 10.1002/prp2.70130.

Reference Type DERIVED
PMID: 40517312 (View on PubMed)

Other Identifiers

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2020120989remimazolam

Identifier Type: -

Identifier Source: org_study_id