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The availability and safety study of Remimazolam Besylate for injection on sedation of sepsis patients under mechanical ventilation in ICU

The availability and safety study of Remimazolam Besylate for injection on sedation of sepsis patients under mechanical ventilation in ICU

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076671
Enrollment
Unknown
Registered
2023-10-16
Start date
2023-10-16
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Sepsis

Interventions

Experimental Group:Remimazolam besylate for injection
Positive Control Group:Midazolam

Sponsors

The first affiliated hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18–80 years old. 2. Meet criteria of Sepsis 3.0, diagnosed sepsis within 48 hours. 3. SOFA score plus 2. 4. Patients with mechanical ventilation require sedative treatment. 5. Clearly know the purpose and objective of this clinical study and voluntarily enrolled.

Exclusion criteria

Exclusion criteria: 1. Aged less than 18–80 years old. 2. Woman in gestation and lactation period. 3. Allergy to componen to Remimazolam besylate for injection. 4. Patients with autoimmune diseases or those who have been using immunosuppressants for a long time. 5. Individuals with a history of severe arrhythmia. 6. Any condition in which remidazolam besylate for injection or midazolam is not suitable for sedation treatment. 7. The next of kin of each patients refuse to participate in this clinical trial. 8. Other circumstance that identified by researchers that do not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
RASS Score;

Secondary

MeasureTime frame
CPOT Score;MAP;

Countries

China

Contacts

Public ContactWu Haiying

The first affiliated hospital of Kunming Medical University

459803340@qq.com+86 138 8853 3412

Outcome results

None listed

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