Pain in elderly mechanical ventilation patients
Conditions
Interventions
Experimental group:Tegileridine Fumarate Injection
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years (gender not restricted); 2. Body Mass Index (BMI) 18.5 - 28.0 kg/m^2; 3. At the time of enrollment, mechanical ventilation had been received and the duration was less than 48 hours; 4. The expected duration of subsequent mechanical ventilation is >= 24 hours; 5. The patient voluntarily participated in this study and signed the informed consent form by themselves or their legal representative.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to the investigational drug or any of its excipients; 2.History of drug abuse, alcohol abuse, chronic pain, or long-term opioid use; 3.Severe psychiatric illness, or inability to undergo Richmond Agitation-Sedation Scale (RASS) or Critical-Care Pain Observation Tool (CPOT) assessment due to neuromuscular blocker use, severe central nervous system injury, or other causes; 4.Severe hepatic impairment (e.g., Child-Pugh Class C); 5.Mechanical intestinal obstruction, intestinal ischemia, gastrointestinal perforation, or severe gastrointestinal motility disorder; 6.Pregnant or lactating women; 7.Participation in another interventional clinical trial within 30 days prior to enrollment; 8.Moribund state, or an expected survival of < 48 hours as assessed by the investigator; 9.Any other condition deemed by the investigator to render the subject unsuitable for this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Unconsciousness or Excessive Sedation;Rescue analgesic requirement;Sedative dosage;Rate of analgesic target attainment;Incidence of delirium;Respiratory Adverse Events (RAEs);Weaning Time;Gastrointestinal dysfunction;ICU-free days within 28 days;Ventilator-free days within 28 days;Total length of hospital stay (LOS);Rate of re-intubation;28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactJing Zhou
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed