Skip to content

Study on the effective dose of fospropofol disodium for sedation in patients with postoperative mechanical ventilation in ICU

Study on the effective dose of fospropofol disodium for sedation in patients with postoperative mechanical ventilation in ICU

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057111
Enrollment
Unknown
Registered
2022-02-28
Start date
2022-03-10
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Postoperative patient

Interventions

2.0 dose group :Fospropofol disodium 10 mg/kg IV, followed by IV infusion of the corresponding dose of fospropofol disodium, target RASS of -3 to 0 points
2.5 dose group :Fospropofol disodium 10 mg/kg IV, followed by IV infusion of the corresponding dose of fospropofol disodium, target RASS of -3 to 0 points
3.0 dose group :Fospropofol disodium 10 mg/kg IV, followed by IV infusion of the corresponding dose of fospropofol disodium, target RASS of -3 to 0 points
3.5 dose group :Fospropofol disodium 10 mg/kg IV, followed by IV infusion of the corresponding dose of fospropofol disodium, target RASS of -3 to 0 points
4.0 dose group :Fospropofol disodium 10 mg/kg IV, followed by IV infusion of the corresponding dose of fospropofol disodium, target RASS of -3 to 0 points

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Those over the age of 18 but under the age of 75; 2. Body mass index BMI 18~30 kg/m2; 3. Those who were transferred to ICU with tracheal intubation after operation; 4. Those who are expected to require mechanical ventilation >= 8 hours, but < 24 hours; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Previously included in this study; 2. Pregnant women; 3. Breastfeeding women; 4. Severe central nervous system diseases (massive cerebral infarction/cerebral hemorrhage; status epilepticus; severe dementia, etc.); 5. This operation is a brain surgery (after aneurysm interventional embolization may not be excluded); 6. Unable to follow orders due to brain trauma before the operation; 7. This operation is a kidney transplant; 8. This operation is a liver transplant; 9. This operation is cardiovascular surgery; 10. Acute hepatitis; 11. Severe liver disease (Child-Pugh C); 12. Chronic kidney disease (CKD grade 3 and above); 13. Myasthenia gravis; 14. Allergic diseases or allergies to study drugs or drugs with similar structures; 15. Unstable angina or acute myocardial infarction; 16. Left ventricular ejection fraction of 30% or less; 17. Heart rate 15ug/kg/min or epinephrine>0.2ug/kg/min or norepinephrine>0.2ug/kg/min) to maintain SBP above 90mmHg; 20. Alcohol or drug withdrawal; 21. Psychopaths.

Design outcomes

Primary

MeasureTime frame
Effective dose of fospropofol for postoperative patient sedation;

Secondary

MeasureTime frame
Richmond Agitation-Sedation;

Countries

China

Contacts

Public ContactYou Shang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

you_shanghust@163.com+86 15972127819

Outcome results

None listed

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