Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study

B2024-161R

The goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation. It will also assess the safety of oxycodone hydrochloride. The main questions it aims to answer are: 1. Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients? 2. What medical problems do participants have when using oxycodone hydrochloride? Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients. Participants will: * Receive either oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h or remifentanil injection at a dose of 2-9 μg/kg/h. * Have their pain scores assessed every 15 minutes until the CPOT score is less than 3. After reaching the target pain score, assessments will be done every 4 hours. * Have their vital signs and monitoring data recorded. * Have analgesia and sedation scores recorded from days 1 to 7 after administration, with drug dosages adjusted based on pain scores. * Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration. * If extubated within 7 days, relevant data will be collected based on the time of extubation. * Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period.

2024-06-01

2025-02-28

2025-12-31

Not yet recruiting

Early phase I

60

Inclusion Criteria: * 18 ≤ Age ≤ 80 * Intubated and mechanically ventilated \< 3 days prior to enrollment * Expected need for continuous mechanical ventilation ≥ 24 hours Exclusion Criteria: * Patients requiring deep sedation (e.g., mechanical ventilation patients with severe man-machine dyssynchrony, respiratory distress due to severe respiratory failure, application of neuromuscular blockers, status epilepticus, surgical procedures requiring strict immobilization, mild hypothermia treatment, etc.); * Chronic kidney disease, severe liver dysfunction (Child-Pugh Class C) * Severe shock requiring norepinephrine ≥ 0.5 µg/kg/min * American Society of Anesthesiologists (ASA) Class 5 patients (near death) * Nerve injury or organic pathological changes in the brain * Need for designated sedatives or anesthetics other than study drug during treatment * Patients with chronic pain, frequently taking strong opioids, such as morphine * History of alcohol or drug abuse * Participation in other opioid studies within 30 days * Pregnant or lactating women * Patients with study drug allergy and contraindications Patients who are not suitable for inclusion in the study as judged by the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-06-06