analgesia in ICU patients
Conditions
Interventions
Experimental group:The oliceridine fumarate injection will be administered for analgesia. Loading dose: 1.5 mg (at the investigator’s discretion based on clinical practice). Maintenance dose during me
Control group:Conventional analgesics will be administered for analgesia. (dosage and administration as specified in Appendix 7 of the study protocol). The actual dose will be determined by the invest
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age=12 hours and <=14 days. 5.Patients or their legally authorized representatives have fully understood and agreed to the purpose and significance of this study, can comply with all study requirements, voluntarily participate, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity or contraindication to any component of the investigational drug(s) used in this study; 2.Patients who, for any reason, cannot undergo RASS or CPOT assessment (detailed assessment methods are provided in Appendix 1 and Appendix 2 of the study protocol); 3.History of myasthenia gravis; 4.History of bronchial asthma; 5.Severe hepatic dysfunction [Child–Pugh class C (10~15 points); detailed assessment methods are provided in Appendix 5 of the study protocol]; 6.Patients requiring the use of neuromuscular blocking agents; 7.History of drug abuse, illicit drug use, or severe alcoholism within 2 years prior to screening, or regular long-term use of psychotropic drugs (continuous use for more than 30 days) within 3 months prior to screening; 8.Participation as a subject in any clinical trial (drug or device) within 1 month prior to enrollment; 9.Pregnant or lactating women; 10.Any other condition deemed inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous Mechanical Ventilation Duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients Achieving Pain Control Within 72 Hours After Study Drug Administration;Total Opioid Consumption During Study Drug Administration;First Weaning Success Rate(WSR);Proportion of Patients Experiencing Respiratory Depression After Extubation;28-Day Ventilator-Free Days;28-Day ICU Length of Stay (days);28-Day All-Cause Mortality (%); | — |
Countries
China
Contacts
Public ContactYan Kang
West China Hospital, Sichuan University
Outcome results
None listed