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Ciprofol versus Propofol for Sedation in Mechanically Ventilated Adults with Sepsis: A Randomized Controlled, Non-inferiority Trial

Ciprofol versus Propofol for Sedation in Mechanically Ventilated Adults with Sepsis: A Randomized Controlled, Non-inferiority Trial - Ciprofol versus Propofol for Sedation in Mechanically Ventilated Adults with Sepsis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066835
Enrollment
Unknown
Registered
2022-12-19
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Adults with sepsis

Interventions

Propofol group:Propofol

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: We will include patients who are aged 18 years or older, have sepsis (Sepsis-3 definition), need invasive mechanical ventilation for at least 24 hours, and treat with continuous sedation for safety and comfort.

Exclusion criteria

Exclusion criteria: The exclusion criteria will include (1) pregnant or breast-feeding; (2) known or suspected allergy to ciprofol or propofol; (3) psychological illness, severe cognitive dysfunction, or disorder of consciousness; (4) chronic kidney disease requiring dialysis; (5) decompensated chronic liver disease (Child-Pugh class B or C); (6) history of alcoholism or intake of anti-anxiety drugs or hypnotics; (7) body mass index=30; (8) heart rate less than 50 beats/min; (9) refractory shock (mean arterial pressure less than 60 mmHg despite appropriate intravenous volume administration and vasopressors); (10) moribund state or patients in palliative care only.

Design outcomes

Primary

MeasureTime frame
Weaning time;

Secondary

MeasureTime frame
In-hospital mortality;ICU mortality;Pain intensity;Delirium;Cognitive function;Renal function;Inflammatory markers;Immunologic markers;Sequential Organ Failure Assessment (SOFA) score;Length of hospital stay;Length of ICU stay;The doses of sedative drugs;The doses of analgesic drugs;Adverse events and serious adverse events;

Countries

China

Contacts

Public ContactHai-Yan Yin

The First Affiliated Hospital of Jinan University

yinhaiyan1867@126.com13318831222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026