Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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