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.
Postoperative acute pain affects up to 80% of surgical patients. Despite the increasing adoption of multimodal analgesia, opioids remain a mainstay for managing postoperative pain; however, their clinical utility is often constrained by dose-dependent adverse events that compromise recovery quality. Among these, opioid-induced respiratory depression is a serious and potentially fatal complication that may be substantially underestimated owing to its insidious presentation and limitations in routine monitoring. The reported incidence of opioid-induced respiratory depression ranges from 11% to 46%. Obstructive sleep apnea (OSA) is a well-established risk factor for opioid-induced respiratory depression. Perioperative anesthetics exacerbate upper airway collapse and depress central respiratory while disrupted sleep architecture and intermittent nocturnal hypoxia heighten opioid sensitivity. Traditional μ-opioid agonists (e.g., morphine, fentanyl, sufentanil) activate both G-protein and β-arrestin pathways, producing effective analgesia but concurrently causing significant respiratory depression. Oliceridine, a novel biased μ-opioid receptor agonist approved by the FDA in 2020, selectively engages the G-protein pathway while reducing β-arrestin recruitment, theoretically mitigating respiratory depression risk. Phase III trials and subsequent pooled analyses confirmed that oliceridine was associated with a lower respiratory event burden and fewer composite adverse events compared with morphine at equianalgesic doses. Recent data further supported its favorable respiratory safety profile and a wider safety margin in older patients. Nevertheless, regarding the incidence of respiratory depression, high-quality evidence comparing oliceridine with sufentanil for postoperative analgesia in patients who are diagnosed with or suspected to be at high risk of OSA remains limited. This observational study aims to compare the incidence of respiratory depression within 24 hours postoperatively between oliceridine and sufentanil in surgical patients with confirmed or suspected OSA.
Study Type
OBSERVATIONAL
Enrollment
851
Oliceridine will be administered via patient-controlled intravenous analgesia.
Sufentanil will be administered via patient-controlled intravenous analgesia.
Peking University Fist Hospital
Beijing, China
Incidence of respiratory depression 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.
Time frame: Within 24 hours after surgery
Quality of recovery on postoperative day 1
Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluate the quality of early postoperative recovery after surgery and anesthesia. Scores range from 0 to 150, with higher scores indicating better quality of recovery)
Time frame: On postoperative day 1.
Incidence of postoperative nausea and vomiting
Any event of nausea or vomiting
Time frame: Within 72 hours after surgery
Area under curve (AUC) of pain intensity at rest and during movement
Pain intensity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at predefined time-points until 72 hours after surgery. The area under curve of pain intensity will be calculated using the trapezoidal rule.
Time frame: Within 72 hours after surgery
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