Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients with confirmed or suspected OSA who are scheduled to undergo noncardiac surgery and require patient-controlled intravenous analgesia after surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Oliceridine
DrugOliceridine will be administered via patient-controlled intravenous analgesia.
Sufentanil
DrugSufentanil will be administered via patient-controlled intravenous analgesia.
Treatment groups
851 Participants
are divided into 2 treatment groupsGroup A: Oliceridine cohort1 intervention
Group B: Sufentanil cohort1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 1.2
Incidence of postoperative nausea and vomiting
Any event of nausea or vomiting
Time frame
Within 72 hours after surgery3
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 surgeryOther outcomes
1
Cumulative opioid consumption
Cumulative opioid consumption will be calculated as intravenous sufentanil equivalent dosage.
Time frame
Within 72 hours after surgery2
Rescue analgesic consumption
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
Within 72 hours after surgery3
Subjective sleep quality
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
On the first three postoperative nights4
Incidence of respiratory depression within 48 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 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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