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Impact of Fospropofol disodium and Remifentanil Combination Therapy for Analgesia and Sedation on Mechanical Ventilation Weaning, Sleep, and Delirium in Patients with Mild to Moderate ARDS: A Prospective, Randomized, Controlled, Multicenter Clinical Study

Impact of Fospropofol disodium and Remifentanil Combination Therapy for Analgesia and Sedation on Mechanical Ventilation Weaning, Sleep, and Delirium in Patients with Mild to Moderate ARDS: A Prospective, Randomized, Controlled, Multicenter Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098766
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Analgesics-sedatives

Interventions

Control group (Midazolam):midazolam group:loading dose0.01-0.05mg/kg, Maintenance dose 0.02-0.1mg/kg/h

Sponsors

Shandong University Qilu Hospital (Qingdao)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years old and < 80 years old; (2) meet the diagnostic criteria for mild to moderate ARDS; (3) mechanical ventilation for less than 48 hours prior to inclusion in the study; and (4) obtaining informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients requiring neuromuscular blocking agents or ECMO treatment; (2) Patients with severe heart disease, with LVEF < 50% or NYHA class III or higher; (3) Patients with severe hepatic or renal insufficiency (Child-Pugh class C or higher, CKD stage 4 or higher); (4) Patients with severe central nervous system diseases, such as traumatic brain injury, cerebral hemorrhage, cerebral infarction, or uncontrolled epilepsy; (5) Patients with neuromuscular diseases such as myasthenia gravis, Guillain-Barre syndrome, Parkinson's disease, Alzheimer's disease, etc.; (6) Patients with an estimated survival time of < 48 hours; (7) Patients with a history of drug abuse, addiction, alcoholism, or long-term use of psychotropic drugs within the past 2 years prior to screening, or patients with chronic pain requiring long-term opioid therapy; (8) Any condition that prevents accurate assessment of cognitive function, such as language and sensory impairments or mental disorders (difficulty speaking or severe organic mental dysfunction); (9) Patients with severe arrhythmias, such as second-degree or third-degree atrioventricular block, severe bradycardia, etc.; (10) Pregnant or lactating women; (11) Patients for whom informed consent or authorization cannot be obtained; (12) Patients allergic toFospropofol disodium or other trial-related drugs; (13) Other situations deemed inappropriate for inclusion in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
28 days of mechanical ventilation-free time;

Secondary

MeasureTime frame
Sleep quality;Incidence of delirium;Length of stay in ICU and Length Of Stay;Total amount of analgesic and sedative drugs used;Heart rate mean arterial pressure and respiratory rate ;

Countries

China

Contacts

Public ContactGuo Xi

Shandong University Qilu Hospital (Qingdao)

guoxiqd@qiluhospital.com+86 185 6181 0100

Outcome results

None listed

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