Skip to content

Comparison of clinical application of remazolam besylate and midazolam in ICU patients

Comparison of clinical application of remazolam besylate and midazolam in ICU patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045016
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Patients requiring sedation in the ICU

Interventions

Remazolam besylate group:Sedation with remazolam besylate
Midazolam group:sedation with midazolam

Sponsors

Affiliated Hospital of Putian University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and 3 days; 3. Obtain informed consent from patients or family members.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Those who need general anesthesia surgery within 48 hours; 3. Severe, existing substantial liver disease with clinically significant portal hypertension, Child-Pugh C cirrhosis or acute liver failure; 4. Patients with acute or chronic renal insufficiency requiring dialysis; 5. Severe head injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, status epilepticus, etc.; 6. Patients with a history of alcohol or drug abuse; 7. Any situation that hinders the correct assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or mental organic dysfunction); 8. Participate in other exploratory clinical trials within 6 months before screening; 9. Known or suspected allergy to remazolam, midazolam and opioids.

Design outcomes

Primary

MeasureTime frame
The average total dose required for propofol remediation to maintain target sedation;the time of mechanical ventilation;

Secondary

MeasureTime frame
Vital signs;APACHE II score;Blood routine examination;

Countries

China

Contacts

Public ContactChen Ming

Affiliated Hospital of Putian University

chenm200688@126.com+86 13706057589

Outcome results

None listed

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