Pain
Conditions
Interventions
Comparator group:Remifentanil and Propofol
Study group:Oxycodone and Propofol
Sponsors
Rugao People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years, inclusive. 2. Body Mass Index (BMI) greater than 18 kg/m² and less than 30 kg/m². 3. Admitted to the ICU with an anticipated requirement for mechanical ventilation >= 24 hours. 4. Hemodynamically stable.
Exclusion criteria
Exclusion criteria: 1. History of allergy to opioids. 2. Long-term use of analgesic medications. 3. Neuropsychiatric disorders requiring pharmacological treatment. 4. Combined with traumatic brain injury and/or cerebrovascular accident. 5. Treatment with neuromuscular blocking agents. 6. Cognitive impairment. 7. Brain death or vegetative state. 8. Pregnancy. 9. Participation in another clinical trial within the previous 30 days. 10. Abnormal liver or renal function (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) and/or Total Bilirubin (TBiL) >= 2 × Upper Limit of Normal (ULN); Serum Creatinine (Cr) >= 2 × ULN, or patients requiring renal replacement therapy). 11. History of drug abuse and/or alcohol abuse within the recent 3 months. Alcohol abuse is defined as an average daily intake of > 2 standard alcohol units (1 unit = 360 mL of beer [5% alcohol] or 45 mL of spirits [40% alcohol] or 150 mL of wine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the time to achieve ideal analgesic and sedative effects after mechanical ventilation and the total dosage of analgesics and sedatives used.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in propofol dose between groups;Differences in awakening time between groups after implementing daily wake-up following discontinuation of analgesics and sedatives;Differences in hemodynamic changes and vasoactive drug usage;CPOT (Critical-Care Pain Observation Tool) scores;RASS (Richmond Agitation-Sedation Scale) scores;SMH scores ;Total duration of mechanical ventilation;Length of ICU stay and total hospital stay;Incidence of adverse events such as delirium; | — |
Countries
China
Contacts
Public ContactZhang Juan
Rugao People's Hospital
Outcome results
None listed