Obstructive Sleep ApneaOSANCT07753785
Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Postoperative Analgesia, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea, Postoperative Analgesia, Oliceridine
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- How many people
- 851 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with confirmed or suspected OSA who are scheduled to undergo noncardiac surgery and require patient-controlled intravenous analgesia after surgery.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Fist Hospital
Beijing, 100034
Xue Li, MD, +86 18810527114, 3999165@163.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea, Postoperative Analgesia, Oliceridine, Sufentanil, Respiratory Depression
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Obstructive sleep apnea, Postoperative analgesia, Oliceridine, Sufentanil, Respiratory depression
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Oliceridine will be administered via patient-controlled intravenous analgesia.
SufentanilDrug
Sufentanil will be administered via patient-controlled intravenous analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine cohort | Patients will receive oliceridine via patient-controlled intravenous analgesia. Receives: Drug: Oliceridine | |
| Sufentanil cohort | Patients will receive sufentanil via patient-controlled intravenous analgesia. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Within 24 hours after surgery
Secondary outcomes (3)
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）
Measured: On postoperative day 1.
Incidence of postoperative nausea and vomiting
Any event of nausea or vomiting
Measured: 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.
Measured: Within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 851 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753785
- Sponsor's protocol ID
- 2026R0363
- Acronym
- OSA
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration: An Updated Report by the American Society of Anesthesiologists Task Force on Neuraxial Opioids and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2016 Mar;124(3):535-52. doi: 10.1097/ALN.0000000000000975. No abstract available.
PubMed 26655725Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.
PubMed 20010421Yao X, Wang Z, Zhang Y, Jia W, Sheng X, Zhou Y, Xu C, Jiao H. Oxycodone versus Sufentanil for Postoperative Recovery in Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Oct 17;19:9387-9397. doi: 10.2147/DDDT.S548173. eCollection 2025.
PubMed 41127367Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.
PubMed 40446423Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.
PubMed 36538359Ayad S, Demitrack MA, Burt DA, Michalsky C, Wase L, Fossler MJ, Khanna AK. Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain. Clin Drug Investig. 2020 Aug;40(8):755-764. doi: 10.1007/s40261-020-00936-0.
PubMed 32583295Hammer GB, Khanna AK, Michalsky C, Wase L, Demitrack MA, Little R, Fossler MJ, Ayad S. Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials. Pain Ther. 2021 Dec;10(2):1343-1353. doi: 10.1007/s40122-021-00299-0. Epub 2021 Aug 5.
PubMed 34351590Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
PubMed 30881102Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
PubMed 31162798Markham A. Oliceridine: First Approval. Drugs. 2020 Nov;80(16):1739-1744. doi: 10.1007/s40265-020-01414-9.
PubMed 33025536Ramachandran SK, Haider N, Saran KA, Mathis M, Kim J, Morris M, O'Reilly M. Life-threatening critical respiratory events: a retrospective study of postoperative patients found unresponsive during analgesic therapy. J Clin Anesth. 2011 May;23(3):207-13. doi: 10.1016/j.jclinane.2010.09.003.
PubMed 21570616Gupta K, Nagappa M, Prasad A, Abrahamyan L, Wong J, Weingarten TN, Chung F. Risk factors for opioid-induced respiratory depression in surgical patients: a systematic review and meta-analyses. BMJ Open. 2018 Dec 14;8(12):e024086. doi: 10.1136/bmjopen-2018-024086.
PubMed 30552274Cozowicz C, Chung F, Doufas AG, Nagappa M, Memtsoudis SG. Opioids for Acute Pain Management in Patients With Obstructive Sleep Apnea: A Systematic Review. Anesth Analg. 2018 Oct;127(4):988-1001. doi: 10.1213/ANE.0000000000003549.
PubMed 29958218Turan A, You J, Egan C, Fu A, Khanna A, Eshraghi Y, Ghosh R, Bose S, Qavi S, Arora L, Sessler DI, Doufas AG. Chronic intermittent hypoxia is independently associated with reduced postoperative opioid consumption in bariatric patients suffering from sleep-disordered breathing. PLoS One. 2015 May 26;10(5):e0127809. doi: 10.1371/journal.pone.0127809. eCollection 2015.
PubMed 26010491Messineo L, Bakker JP, Cronin J, Yee J, White DP. Obstructive sleep apnea and obesity: A review of epidemiology, pathophysiology and the effect of weight-loss treatments. Sleep Med Rev. 2024 Dec;78:101996. doi: 10.1016/j.smrv.2024.101996. Epub 2024 Aug 30.
PubMed 39244884
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07753785
- Acronym / sponsor ID
- OSA / 2026R0363
- Conditions
- Obstructive Sleep Apnea, Postoperative Analgesia, Oliceridine, Sufentanil, Respiratory Depression
- Keywords
- Obstructive sleep apnea, Postoperative analgesia, Oliceridine, Sufentanil, Respiratory depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 851 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oliceridine cohort | – | Drug: OliceridinePatients will receive oliceridine via patient-controlled intravenous analgesia. |
| Sufentanil cohort | – | Drug: SufentanilPatients will receive sufentanil via patient-controlled intravenous analgesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with confirmed or suspected OSA who are scheduled to undergo noncardiac surgery and require patient-controlled intravenous analgesia after surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OliceridineOliceridine will be administered via patient-controlled intravenous analgesia. | Drug | Oliceridine cohort |
| SufentanilSufentanil will be administered via patient-controlled intravenous analgesia. | Drug | Sufentanil cohort |
Primary outcome
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: 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.
3 secondary outcomes
Quality of recovery on postoperative day 1
Time frame: On postoperative day 1.
Incidence of postoperative nausea and vomiting
Time frame: Within 72 hours after surgery
Area under curve (AUC) of pain intensity at rest and during movement
Time frame: Within 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 26655725Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration: An Updated Report by the American Society of Anesthesiologists Task Force on Neuraxial Opioids and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2016 Mar;124(3):535-52. doi: 10.1097/ALN.0000000000000975. No abstract available.
- Background: PubMed 20010421Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.
- Background: PubMed 41127367Yao X, Wang Z, Zhang Y, Jia W, Sheng X, Zhou Y, Xu C, Jiao H. Oxycodone versus Sufentanil for Postoperative Recovery in Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Oct 17;19:9387-9397. doi: 10.2147/DDDT.S548173. eCollection 2025.
- Background: PubMed 40446423Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.
- Background: PubMed 36538359Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.
- Background: PubMed 32583295Ayad S, Demitrack MA, Burt DA, Michalsky C, Wase L, Fossler MJ, Khanna AK. Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain. Clin Drug Investig. 2020 Aug;40(8):755-764. doi: 10.1007/s40261-020-00936-0.
- Background: PubMed 34351590Hammer GB, Khanna AK, Michalsky C, Wase L, Demitrack MA, Little R, Fossler MJ, Ayad S. Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials. Pain Ther. 2021 Dec;10(2):1343-1353. doi: 10.1007/s40122-021-00299-0. Epub 2021 Aug 5.
- Background: PubMed 30881102Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
- Background: PubMed 31162798Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
- Background: PubMed 33025536Markham A. Oliceridine: First Approval. Drugs. 2020 Nov;80(16):1739-1744. doi: 10.1007/s40265-020-01414-9.
- Background: PubMed 21570616Ramachandran SK, Haider N, Saran KA, Mathis M, Kim J, Morris M, O'Reilly M. Life-threatening critical respiratory events: a retrospective study of postoperative patients found unresponsive during analgesic therapy. J Clin Anesth. 2011 May;23(3):207-13. doi: 10.1016/j.jclinane.2010.09.003.
- Background: PubMed 30552274Gupta K, Nagappa M, Prasad A, Abrahamyan L, Wong J, Weingarten TN, Chung F. Risk factors for opioid-induced respiratory depression in surgical patients: a systematic review and meta-analyses. BMJ Open. 2018 Dec 14;8(12):e024086. doi: 10.1136/bmjopen-2018-024086.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Xin Wang, MD, PhD study director
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Postoperative Analgesia, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Li, MD (+86 18810527114, 3999165@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory depression within 24 hours after surgery (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753785, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.