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A single-center, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of cypofol versus dexmedetomidine plus propofol for sedation in mechanically ventilated patients in intensive care units (ICU)

A single-center, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of cypofol versus dexmedetomidine plus propofol for sedation in mechanically ventilated patients in intensive care units (ICU)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111478
Enrollment
Unknown
Registered
2025-10-31
Start date
2023-01-16
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Mechanical ventilation in ICU

Interventions

Control group:Dexmedetomidine + Propofol
Treatment group:Cyclophorol

Sponsors

The Second Hospital,University of South China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients requiring mechanical ventilation via endotracheal intubation, with an anticipated need for at least 24 hours of sedation post-randomisation; 2. Target RASS sedation score within 0 to -4 points; 3. Age 18 years <= age <= 80 years, gender unrestricted; 4. Body mass index (BMI) 18 kg/m² <= BMI <=30 kg/m²; 5. The patient or their family members fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.known allergies to eggs, soy products, opioids and their relief drugs, propofol, cyclopofol, dexmedetomidine, etc. Propofol, cyclopofol, dexmedetomidine, opioids and their relief drugs contraindicated; 2.Patients who have been sedated for more than 3 days in the ICU or in the general ward before being transferred to the ICU; 3.During the screening period, patients with severe cardiovascular, neurological/psychiatric, liver and kidney diseases were assessed by the researchers as having great risk of sedation/anesthesia, so they should not participate in the study; 4.near-death state, or the expected survival period is not more than 72 hours; 5.Pregnant or lactating women; 6.Other conditions in which the investigator determines that the patient is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Average sedation attainment rate;Mean time to reach sedation target;recovery time;extubation time;Mechanical ventilation time;length of ICU stay;

Countries

China

Contacts

Public ContactCaihong Yan

The Second Hospital,University of South China

27593247@qq.com+86 734 8288081

Outcome results

None listed

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