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A single-center, single-blind, randomized controlled observational study comparing different treatment regimens

Observation on the safety and efficacy of phosphopropofol disodium in fibrobronchoscopy for ICU patients with mechanical ventilation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107191
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Patients in the ICU who need fiberoptic bronchoscopy for mechanical ventilation

Interventions

Phosphopropofol disodium group:Phosphopropofol disodium
Propofol group:Propofol

Sponsors

Liaocheng People's 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, gender not limited; 2. Patients admitted to the ICU who require invasive mechanical ventilation and fiberoptic bronchoscopy; 3. Obtain the informed consent of the patient or their family.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Patients with a history of alcohol or drug abuse; 3. Patients with acute hepatitis and severe liver diseases (Child-Pugh grade C); 4. Bradycardia (second/third degree atrioventricular block); 5. Receiving two or more sedative or analgesic drugs in the ICU within 24 hours; 6. Patients allergic to disodium phosphopropofol and propofol; 7. Any situation that hinders the correct assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or mental organic functional disorders); 8. Unable to obtain informed consent or authorization; 9. Participate in other exploratory clinical trials within 6 months before screening.

Design outcomes

Primary

MeasureTime frame
The time it takes to achieve the ideal sedation goal;The time it takes to regain consciousness after the examination;Operation time of bronchoscopy;The number of cases that failed to reach the sedation target;

Secondary

MeasureTime frame
hospital stays;Changes in heart rate, blood pressure, blood oxygen saturation and respiratory rate per minute;Incidence of adverse events;In-hospital /ICU mortality rate;icu staying;The occurrence of bronchospasm;

Countries

China

Contacts

Public ContactTian Hui

Liaocheng People's Hospital

tianhui_jeff@163.com+86 635 827 6324

Outcome results

None listed

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