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Comparison of sedation therapy between remazolam and midazolam in ICU mechanically ventilated patients

Clinical application of remazolam in continuous sedation in ICU mechanically ventilated patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060314
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-06-17
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Interventions

experimental group:Remazolam maintained sedation at 0.1 to 0.3 mg/kg/h, with the goal of achieving a RASS score of - 1 to 0.
control group:Midazolam maintains sedation (adjusted for age, weight, etc.) with a goal of achieving a RASS score of -1 to 0.

Sponsors

Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Receive invasive mechanical ventilation; 3. It is expected that the extubation conditions cannot be achieved within 48 hours and the expected ICU hospitalization time is greater than 5 days; 4. Sedative drugs are required to ensure comfort, safety and facilitate the implementation of life support measures; 5. The subject or his authorized client gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant women and babies; 2. Severe central nervous system disease, GCS less than 8 points (massive cerebral infarction/hemorrhage; status epilepticus; severe dementia, etc.); 3. Unstable angina or acute myocardial infarction, left ventricular ejection fraction <= 30%; 4. Heart rate < 50 bpm, type 2 second-degree or third-degree atrioventricular block (except for implanted pacemaker); 5. After adequate fluid resuscitation, use two vasoconstrictors to maintain SBP above 90 mmHg; 6. Alcohol or drug withdrawal, mental illness; 7. Hypersensitivity to benzodiazepines such as remimazolam and midazolam.

Design outcomes

Secondary

MeasureTime frame
Arterial blood pressure;Heart rate;Respiratory rate;Confusion Assessment Method, CAM-ICU;The Richmond Agitation-Sedation Scale, RASS;Self-Rating Depression Scale, SDS;

Primary

MeasureTime frame
Duration of mechanical ventilation;EEG waveform changes during sedation maintenance;

Countries

China

Contacts

Public ContactHuang Man

The Second Affiliated Hospital of Medical College of Zhejiang University

13456644468@163.com+86 13906518699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026