Oliceridine: Oliceridine will be administered via patient-controlled intravenous analgesia.
Sufentanil: Sufentanil will be administered via patient-controlled intravenous analgesia.
Study summary
Opioids are frequently used for postoperative analgesia but may induce side effects. Opioid-induced respiratory depression is the most dangerous side effect of opioids. Patients with obstructive sleep apnea (OSA) are at higher risk for opioid-induced respiratory depression. Oliceridine is a novel biased μ-opioid receptor agonist that selectively engages the G-protein pathway while reducing β-arrestin recruitment and thus may lower the risk of respiratory depression. The goal of this observational study is to compare the effects of oliceridine versus sufentanil analgesia on the incidence of postoperative respiratory depression in patients with known or suspected OSA in the postoperative period following elective surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 18 to 90 years.
* Diagnosed with obstructive sleep apnea according to polysomnography, or suspected to be at high risk of moderate-to-severe OSA according to the STOP-Bang questionnaire: (1) STOP-Bang score ≥ 5; (2) STOP-Bang score ≥ 3 with serum bicarbonate \[HCO₃-\] ≥ 28 mmol/L; (3) STOP score ≥ 2 and male sex; (4) STOP score ≥ 2 and body mass index (BMI) \> 35 kg/m²; or (5) STOP score ≥ 2 and neck circumference \> 40 cm.
* Scheduled to undergo elective non-cardiac surgery under general anesthesia.
* Required patient-controlled intravenous analgesia (PCIA) after surgery.
Exclusion Criteria:
* Pregnant or lactating women.
* Scheduled to undergo pulmonary/thoracic surgery in the current admission;
* Planning to receive use of epidural analgesia.
* Preplanned postoperative admission to the intensive care unit (ICU) or requirement for mechanical ventilation.
Primary outcome measure(s)
Incidence of respiratory depression within 24 hours after surgery — Within 24 hours after surgery Respiratory depression is defined as the occurrence of any of the following during the observation period:
1. Respiratory rate ≤ 8 breaths/min, persisting for \> 1 minute;
2. SpO₂ ≤ 90%, persisting for \> 1 minute;
3. End-tidal CO₂ (EtCO₂) ≤ 15 mmHg or ≥ 60 mmHg, persisting for \> 1 minute;
4. Apnea \> 30 seconds;
5. Clinical situations requiring intervention: mask oxygenation (FiO₂ \> 6 L/min) or high-flow nasal oxygen; insertion of oropharyngeal, nasopharyngeal, or supraglottic/subglottic airway devices; jaw thrust; non-invasive/invasive ventilation; administration of naloxone; unplanned ICU admission.
Trial sites (1)
Facility
City
Region
Status
Peking University Fist Hospital
Beijing
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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