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Clinical study of Fospropofol for sedation of ICU patients

Clinical study of Fospropofol for sedation of ICU patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072688
Enrollment
Unknown
Registered
2023-06-21
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Analgesics-sedatives

Interventions

Experimental group (Fospropofol group):Fospropofol group : loading dose 1-3mg/kg, Maintenance dose 1-4mg/kg/h
Control group (Midazolam group):Midazolam group : loading dose 0.01-0.05mg/kg, Maintenance dose 0.02-0.1mg/kg/h

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Age = 18 years old; (2)Patients admitted to ICU requiring sedation; (3)Obtain informed consent from the patient or family.

Exclusion criteria

Exclusion criteria: (1)Age< 18 years old; (2)Long-term use of benzodiazepines or psychotropic drugs; (3)Presence of severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, persistent status epilepticus, etc; (4)Any condition that prevents the correct assessment of cognitive function, such as language and sensory impairment or psychiatric disorders (language difficulties or psycho-organic dysfunction); (5)Patients with allergies to test-related drugs; (6)Participation in other exploratory clinical trials within 6 months prior to screening; (7)Unable to obtain informed consent or authorization.

Design outcomes

Primary

MeasureTime frame
Time to achieve target sedation after administration of test drug;

Secondary

MeasureTime frame
Duration of mechanical ventilation;Remediation rates requiring other drugs in combination with sedation;ICU hospitalization time;Total hospitalization time;

Countries

China

Contacts

Public Contactxiufen yang

The First Hospital of Hebei Medical University

906036418@qq.com+86 186 3388 9857

Outcome results

None listed

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