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The use of fospropofol disodium injection combined with remifentanil for analgesic and sedative treatment during fiberoptic bronchoscopy in critically ill patients:A single-center, randomized controlled clinical study

The use of fospropofol disodium injection combined with remifentanil for analgesic and sedative treatment during fiberoptic bronchoscopy in critically ill patients:A single-center, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092766
Enrollment
Unknown
Registered
2024-11-22
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-02

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 group):Administer midazolam slowly via bolus injection at a dose of 1-3 mg, and if the procedure exceeds 20 minutes, administer an additional 1-3 mg of midazolam.

Sponsors

Shandong University Qilu Hospital (Qingdao)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old <= age <80 years old; (2) Patients admitted to the ICU who require tracheal intubation and ventilator-assisted ventilation, and who also need to undergo fiberoptic bronchoscopy; (3) Obtaining informed consent from the patient or their family members.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women; (2) Patients with a history of drug abuse, addiction, alcoholism, or long-term use of psychotropic drugs within the past 2 years before screening, or patients with chronic pain requiring long-term opioid use; (3) Patients in the terminal stage of cancer or with multiple organ failure with an expected survival time of less than 48 hours; (4) Patients with any condition that impairs the correct assessment of cognitive function, such as brain injury, stroke, brain tumor, central nervous system infection, epilepsy, as well as language and sensory impairments or mental disorders (e.g., difficulty in speaking or severe organic mental dysfunction); (5) Participation in other exploratory clinical trials within 6 months prior to screening; (6) Inability to obtain informed consent or authorization; (7) Patients allergic to the test drugs or their excipients; (8) Severe liver impairment (Child-Pugh Class C or higher); (9) Chronic renal insufficiency or severe acute renal injury (KDIGO Stage II or higher); (10) Presence of arrhythmias, acute myocardial infarction, or severe cardiac insufficiency (NYHA Class III or higher).

Design outcomes

Primary

MeasureTime frame
heart rate;mean arterial pressure;respiratory rate;

Secondary

MeasureTime frame
duration of mechanical ventilation;

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