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A Study of the Safety and Efficacy of remimazolam besylate in combination with remifentanil in mechanically ventilated patients in the EICU

A Study of the Safety and Efficacy of remimazolam besylate in combination with remifentanil in mechanically ventilated patients in the EICU

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099897
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None

Interventions

Experimental Group:Remimazolam besylate
control group:Propofol

Sponsors

Huzhou Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old and <= 75 years old; 2.The estimated duration of mechanical ventilation = 48 hours; 3.The condition is allowed to be maintained in a state of shallow sedation (RASS -2~0); 4.Obtain informed consent from the patient or family;

Exclusion criteria

Exclusion criteria: 1.Pregnancy or breastfeeding; 2.Patients who require surgery under general anesthesia within 48 hours; 3.Severe, pre-existing parenchymal liver disease with clinically significant portal hypertension, Child-Pugh class C cirrhosis, or acute liver failure; 4.Patients with acute and chronic renal insufficiency requiring dialysis treatment; 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 condition that precludes proper assessment of cognitive function, such as speech and sensory impairment or psychiatric disorders (language difficulties or mental organic dysfunction); 8.Inability to obtain informed consent or authorization; 9.Participation in other exploratory clinical trials within 6 months prior to screening; 10.Known or suspected hypersensitivity to the study drug;

Design outcomes

Primary

MeasureTime frame
Duration of mechanical ventilation;

Countries

China

Contacts

Public Contactxulan

Huzhou Center Hospital

xulan216@sina.com+86 13757077215

Outcome results

None listed

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