The main disease types include respiratory failure, severe infection, trauma, shock, post-cardiac arrest, and multiple organ dysfunction.
Conditions
Interventions
Control group: Midazolam injection + Remifentanil grou:Fospropofol disodium for injection + Remifentanil
Study group:Fospropofol disodium for injection + Remifentanil
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, either gender; 2. Mechanically ventilated patients admitted to the EICU requiring analgesic and sedative therapy; 3. Body mass index (BMI) 18–30 kg/m²; 4. Target analgesia: CPOT score = 0; 5. Target sedation: RASS score -3 to 0; 6. Signed informed consent obtained from the patient or legal representative;
Exclusion criteria
Exclusion criteria: 1. Participated in this or any other interventional study within the past 3 months; 2. BMI 30 kg/m²; 3. Expected survival = 0.5 µg/kg/min); 7. Use of monoamine oxidase inhibitors (MAOIs); 8. Severe liver disease (Child-Pugh Class C cirrhosis or acute liver failure); 9. Alcohol or drug intoxication; 10. History of long-term opioid use or opioid addiction; 11. Known hypersensitivity or contraindication to any study drug; 12. High-risk intestinal obstruction (including paralytic ileus); 13. Acute severe neurological disease or any condition interfering with RASS assessment; 14. Inability to provide informed consent or authorization; 15. Other conditions deemed inappropriate by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of Achieving Target Sedation;Wake-Up Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Mechanical Ventilation;Total Dosage of Analgesic and Sedative Drugs;General Comfort Questionnaire (GCQ) Score;EICU Hospitalization Cost;Incidence of Adverse Events;Critical Care Pain Observation Tool (CPOT) Score;In-Hospital Mortality;Richmond Agitation-Sedation Scale (RASS) Score;Length of EICU Stay; | — |
Countries
China
Contacts
Public ContactDeng Lei
Sichuan Provincial People's Hospital
Outcome results
None listed