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

NCT05480787 | Unknown Phase 4

• 1 other identifier: 2020120989remimazolam
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Remimazolam; Intensive Care Unit; Mechanical Ventilation; Anesthesia; Sedation; Liver Failure; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Remimazolam

  Plasma concentration of Remimazolam

  24 hours

Secondary Outcomes (1)

• Adverse reactions

  28 days

Study Arms (3)

Remimazolam 0.1mg/kg/h

EXPERIMENTAL

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

Drug: Remimazolam 0.1mg/kg/h

Remimazolam 0.3mg/kg/h

EXPERIMENTAL

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

Drug: Remimazolam 0.3mg/kg/h

Remimazolam 0.5mg/kg/h

EXPERIMENTAL

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

Drug: Remimazolam 0.5mg/kg/h

Interventions

Remimazolam 0.1mg/kg/h DRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.1mg/kg/h

Remimazolam 0.3mg/kg/h DRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.3mg/kg/h

Remimazolam 0.5mg/kg/h DRUG

Remimazolam Tosilate for Injection(36mg)

Remimazolam 0.5mg/kg/h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to ICU for tracheal intubation and mechanical; Patients aged \>18 years; Patients with expected mechanical ventialation time \>24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 225500, China

Location

Related Publications (1)

• 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.

  PMID: 40517312 DERIVED

MeSH Terms

Conditions

Liver Failure

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: February 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: September 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

CN (1)