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Clinical study of remazolam benzenesulfonate for sedation in ICU patients with severe pneumonia on invasive mechanical ventilation

Clinical study of remazolam benzenesulfonate for sedation in ICU patients with severe pneumonia on invasive mechanical ventilation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102494
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

severe pneumonia

Interventions

Rimazolam benzenesulfonate group:Rimazolam benzenesulfonate loading dose: 0.2mg/kg, 1min slow sedation, maintenance dose: 0.25-1 mg/kg/h
maintenance of RASS score -2-0, if the depth of sedation is insufficient, add cyclobenzaprine 0.06-0.8mg/kg/h
Midazolam group:Midazolam 0.02-0.1 mg / kg / h, maintain RASS score-2 ~ 0 points, if the depth of sedation is insufficient, add propofol 0.06-0.8 mg / kg / h.

Sponsors

Anhui Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years; 2. Meet the diagnostic criteria for severe pneumonia: conform to the SCAP diagnostic criteria of the 2007 IDSA/ATS guidelines: meet 1 major diagnostic criterion or >=3 minor diagnostic criteria; Secondary diagnostic criteria included: (1) respiratory rate > 30 breaths/min; (2) oxygenation index (Arterial oxygen partial pressure/Inhaled oxygen concentration, PaO2/FiO2) 20 mg/dL; (6) white blood cell count < 4 × 10^9/L; (7) platelet count < 100 × 10^9/L; (8) central body temperature < 36°C; (9) hypotension (systolic blood pressure < 90 mmHg, requiring aggressive fluid resuscitation); 3. Obtaining informed consent from the patient or family.

Exclusion criteria

Exclusion criteria: 1) Age <18 years; 2) Women who are pregnant or are breastfeeding; 3) Hypersensitivity to remazolam or midazolam; (4) Patients with autoimmune diseases or long-term use of immunosuppressive drugs; (5) Patients with a history of severe cardiac arrhythmia; 6) Those whose medical condition does not allow the use of remazolam or midazolam sedation therapy; 7) Patients who refuse to participate in this study by themselves or their families; 8) Any other condition that the investigator considers inappropriate for enrollment; 9) Any condition that prevents the correct assessment of cognitive functioning, such as speech and sensory disorders or psychiatric disorders (speech difficulties or psycho-organic dysfunction); 10) Patients with myasthenia gravis; 11) Patients with a history of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frame
Rass score;

Secondary

MeasureTime frame
blood gas analysis;BBlood routine(CRP);Interleukin 6, IL-6;Absolute lymphocyte count;Sofa score;Mechanical ventilation;

Countries

China

Contacts

Public ContactHaobo Kong

Anhui Chest Hospital

konghaobo2023@163.com+86 185 0569 5239

Outcome results

None listed

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