Peking University Fist Hospital
Beijing, 100034, China
NCT Number: NCT07753785
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Observational
Beijing, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oliceridine will be administered via patient-controlled intravenous analgesia.
Sufentanil will be administered via patient-controlled intravenous analgesia.
Time frame: Within 24 hours after surgery
Respiratory depression is defined as the occurrence of any of the following during the observation period:
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)
Time frame: Within 72 hours after surgery
Any event of nausea or vomiting
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.
Time frame: Within 72 hours after surgery
Cumulative opioid consumption will be calculated as intravenous sufentanil equivalent dosage.
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.
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).
Time frame: Within 48 hours after surgery
Respiratory depression is defined as the occurrence of any of the following during the observation period:
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.
Time frame: Up to 30 days after surgery
Time interval from index surgery to hospital discharge.
Contact information is provided by the study sponsor or research team.
Dong-Xin Wang, MD, PhD
CONTACT
Xue Li, MD
CONTACT
Peking University First Hospital
Other
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
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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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