Effects of Oliceridine Versus Sufentanil Analgesia on Incidence of Postoperative Respiratory Depression in Patients at High-Risk of Obstructive Sleep Apnea: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 851
- 试验地点
- 1
- 主要终点
- Incidence of respiratory depression within 24 hours after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sufentanil cohort
Patients will receive sufentanil via patient-controlled intravenous analgesia.
干预措施: Sufentanil (Drug)
Oliceridine cohort
Patients will receive oliceridine via patient-controlled intravenous analgesia.
干预措施: Oliceridine (Drug)
结局指标
主要结局
Incidence of respiratory depression within 24 hours after surgery
时间窗: 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.
次要结局
- Incidence of postoperative nausea and vomiting(Within 72 hours after surgery)
- Quality of recovery on postoperative day 1(On postoperative day 1.)
- Area under curve (AUC) of pain intensity at rest and during movement(Within 72 hours after surgery)
研究者
Dong-Xin Wang
Professor and the chief of anesthesiology department
Peking University First Hospital