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NCT Number: NCT07753785

Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oliceridine

Drug

Oliceridine will be administered via patient-controlled intravenous analgesia.

Sufentanil

Drug

Sufentanil will be administered via patient-controlled intravenous analgesia.

Primary outcomes

  1. Incidence of respiratory depression within 24 hours after surgery

    Time frame: Within 24 hours after surgery

    Respiratory depression is defined as the occurrence of any of the following during the observation period:

    • Respiratory rate ≤ 8 breaths/min, persisting for > 1 minute;
    • SpO₂ ≤ 90%, persisting for > 1 minute;
    • End-tidal CO₂ (EtCO₂) ≤ 15 mmHg or ≥ 60 mmHg, persisting for > 1 minute;
    • Apnea > 30 seconds;
    • 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.

Secondary outcomes

  1. Quality of recovery on postoperative day 1

    Time frame: 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)

  2. Incidence of postoperative nausea and vomiting

    Time frame: Within 72 hours after surgery

    Any event of nausea or vomiting

  3. Area under curve (AUC) of pain intensity at rest and during movement

    Time frame: Within 72 hours after surgery

    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.

Other outcomes

  1. Cumulative opioid consumption

    Time frame: Within 72 hours after surgery

    Cumulative opioid consumption will be calculated as intravenous sufentanil equivalent dosage.

  2. Rescue analgesic consumption

    Time frame: Within 72 hours after surgery

    Rescue analgesics are defined as any analgesic drugs administered other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.

  3. Subjective sleep quality

    Time frame: On the first three postoperative nights

    Subjective sleep quality will be assessed with the numeric rating scale (NRS; an 11-point where 0=the best sleep and 10=the worst sleep).

  4. Incidence of respiratory depression within 48 hours after surgery

    Time frame: Within 48 hours after surgery

    Respiratory depression is defined as the occurrence of any of the following during the observation period:

    • Respiratory rate ≤ 8 breaths/min, persisting for > 1 minute;
    • SpO₂ ≤ 90%, persisting for > 1 minute;
    • End-tidal CO₂ (EtCO₂) ≤ 15 mmHg or ≥ 60 mmHg, persisting for > 1 minute;
    • Apnea > 30 seconds;
    • 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.
  5. Incidence of postoperative complications during hospital stay

    Time frame: Up to 30 days after surgery

    Postoperative complications are generally defined as new-onset conditions that are deemed harmful and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.

  6. Length of hospital stay after surgery

    Time frame: Up to 30 days after surgery

    Time interval from index surgery to hospital discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

8610 83572784

Xue Li, MD

CONTACT

[email protected]

+86 18810527114

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Acronym: OSA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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