Effect of oliceridine on stress response in mechanically ventilated ICU patients

INTERVENTION: This is a prospective, randomized, active‐controlled, parallel‐group interventional study. Participants are randomly assigned in a 1:1 ratio to receive either oliceridine fumarate (intervention group) or remifentanil hydrochloride (control group). Randomization is performed using a computer‐generated random number table, with participants allocated to one of the two treatment arms in a 1:1 ratio. In the intervention group, oliceridine fumarate is administered intravenously, with a loading dose of 0.03 mg/kg followed by a continuous maintenance infusion starting at 0.0018 mg/kg/min. The infusion rate may be titrated within a range of 0.0006 to 0.045 mg/kg/min according to clinical requirements. In the control group, remifentanil hydrochloride is administered intravenously, with a loading dose of 1 µg/kg followed by a continuous maintenance infusion starting at 0.06 µg/kg/min. The infusion rate may be titrated within a range of 0.02 to 0.15 µg/kg/min as clinically indicated. The study duration is from intubation to extubation. CONDITION: Pain in mechanically ventilated patients ; Signs and Symptoms PRIMARY OUTCOME: Total cortisol level measured using enzyme‐linked immunosorbent assay (ELISA) at baseline and 1‐2 days post‐intervention, twice a day, at 8:00 AM and 4:00 PM SECONDARY OUTCOME: Duration of mechanical ventilation measured using the duration of mechanical ventilation from intubation to extubation at during mechanical ventilation Gastrointestinal dysfunction measured using the timing and frequency of flatulence, dry mouth, dyspepsia, diarrhea, and constipation using patient records at duration of treatment Inflammatory biomarkers, including IL‐1ß, IL‐6, TNF‐a, measured using enzyme‐linked immunosorbent assay (ELISA) at baseline and 1‐2 days post‐intervention Length of stay measured using patient records at end of stay Mortality measured using patient records at until hospital discharge or in‐hospital death INCLUSION CRITERIA: 1. Adult ICU patients requiring endotracheal intubation with mechanical ventilation, and expected to need sedation and analgesia for >24 hours after randomization 2. Target sedation level within a Richmond Agitation‐Sedation Scale (RASS) score of –3 to 0 3. Age =18 years and <80 years, regardless of sex 4. Body mass inde X(BMI) between 18 and 30 kg/m² 5. Patients or their legally authorized representatives fully understand the purpose and significance of the study, voluntarily agree to participate, and provide written informed consent