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Sedative Effect and Safety of Remimazolam Besylate in ARDS Patients

NCT05758597 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-13

No results posted yet for this study

Summary

The incidence and mortality of acute respiratory distress syndrome (ARDS) are high. Patients with ARDS often need mechanical ventilation. Rational use of sedation and analgesia can improve the tolerance of patients with mechanical ventilation and reduce the lung injury caused by mechanical ventilation. Currently, the main sedative drugs used in clinical practice are midazolam, propofol and dexmedetomidine, but they all have disadvantages. It is urgent to find a sedative drug that can achieve rapid and sufficient sedation, does not inhibit breathing, leads to rapid recovery after drug withdrawal and does not increase incidence of delirium.

Remimazolam besylate is a newly marketed ultra-short-acting GABAa receptor agonist, which is not metabolized by liver or kidney and is easily hydrolyzed by non-specific esterase in vivo. It has rapid effect, short recovery time, continuous infusion with almost no accumulation, little influence on respiration and circulation, and can be antagonized by flumasini. Compared with the above traditional sedatives, it has obvious advantages, especially suitable for sedation in ICU patients. There are few studies on remimazolam besylate used for sedation in ICU patients. At present, there is a lack of evidence-based medical evidence for the application of remazolam besylate in ICU patients. Its efficacy and safety, potential advantages and dominant population, application dose and combination of drugs still need to be further explored and clarified. The objective of this study was to investigate the sedative effects and advantages of remimazolam besylate versus midazolam in patients with ARDS requiring invasive mechanical ventilation. The successful undergoing of this study will provide practical basis for clinical sedation in patients with ARDS mechanical ventilation.

Conditions

  • Respiratory Distress Syndrome

Interventions

DRUG

Remazolam besylate

Remazolam benzoate group was given 0.1-1mg/kg/h, and the target RASS score was maintained.

DRUG

midazolam

Meanwhile the midazolam group was given 0.05-0.2 mg/kg/h midazolam, and the target RASS score was maintained.

Sponsors & Collaborators

  • Zhiming Jiang

    lead OTHER

Principal Investigators

  • Zhiming Jiang, doctor · Department of Intensive Care Medicine, Qianfoshan Hospital, Shandong Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-05-01
Completion
2025-06-16

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 NCT05758597 on ClinicalTrials.gov