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Clinical study on sequential sedation with remimazolam benzenesulfonate combined with propofol in ICU patients undergoing mechanical ventilation

Clinical study on sequential sedation with remimazolam benzenesulfonate combined with propofol in ICU patients undergoing mechanical ventilation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091004
Enrollment
Unknown
Registered
2024-10-17
Start date
2021-11-11
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Mechanically ventilated patients admitted to ICU

Interventions

Rimazolam group :Rimazolam group:the sedative medication consisted of a continuous infusion of remimazolam besylate (Yichang Renfu Pharmaceutical, China) at a dosage of 0.1 mg/(kg·h).
propofol group.:The propofol group received an initial intravenous loading dose of propofol (1-2 mg/kg) (Nhwa Pharmaceutical Co., Jiangsu, China), followed by a continuous infusion of propofol at a ra

Sponsors

Affiliated Hospital of Yanbian University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1.age = 18 years old. 2.patients with ICU mechanical ventilation. 3.Obtain the informed consent of the patient or family member.

Exclusion criteria

Exclusion criteria: 1. age =18 year. 2. Pregnancy or lactation. 3. Severe, pre-existing parenchymal liver disease with clinically significant portal hypertension, Child-Pugh C grade liver cirrhosis, or acute liver failure. 4. Patients with bronchial asthma or myasthenia gravis. 4. Patients with bronchial asthma or myasthenia gravis. 5. Patients with a history of alcohol or drug abuse. 6. Any condition that impedes proper assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or organic mental disorders). 7. BMI 35 kg/m^2. 8. There is a history of using monoamine oxidase inhibitors within 14 days, such as phenylethylhydrazine, isoniazid, etc. 9. Unable to obtain informed consent or authorization. 10. Participate in other exploratory clinical trials within 6 months before screening. 11. Allergic to experimental drugs.

Design outcomes

Primary

MeasureTime frame
glutamic pyruvic transaminase;glutamic oxaloacetic transaminase;Triglyceride;Incidence of delirium;mean arterial pressure;creatinine;Cholesterol;Low-density lipoprotein;high-density lipoprotein;

Secondary

MeasureTime frame
ICU length of stay (days);mechanical ventilation time (H), ;sedative medication time (H), ;sedative medication dosage (mg);

Countries

China

Contacts

Public ContactMinggen Jin

Affiliated Hospital of Yanbian University

jinmg@ybu.edu.cn+86 155 2677 0190

Outcome results

None listed

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