Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea

NCT07753785 | Not Yet Recruiting

• 1 other identifier: 2026R0363
• Study Type: observational
• Target: 851
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea; Oliceridine; Sufentanil; Postoperative Analgesia; Respiratory Depression

Keywords

Obstructive sleep apnea; Postoperative analgesia; Oliceridine; Sufentanil; Respiratory depression

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory depression within 24 hours after sugery

  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.

  Within 24 hours after sugery

Secondary Outcomes (3)

• Quality of recovery on postoperative day 1

  On postoperative day 1.

• Incidence of postoperative nausea and vomiting

  Within 72 hours after surgery

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

  Within 72 hours after surgery

Other Outcomes (6)

• Cumulative opioid consumption

  Within 72 hours after surgery

• Rescue analgesic consumption

  Within 72 hours after surgery

• Subjective sleep quality

  On the first three postoperative nights

Study Arms (2)

Oliceridine cohort

Patients will receive oliceridine via patient-controlled intravenous analgesia.

Drug: Oliceridine

Sufentanil cohort

Patients will receive sufentanil via patient-controlled intravenous analgesia.

Drug: Sufentanil

Interventions

Oliceridine DRUG

Oliceridine will be administered via patient-controlled intravenous analgesia.

Oliceridine cohort

Sufentanil DRUG

Sufentanil will be administered via patient-controlled intravenous analgesia.

Sufentanil cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed or suspected OSA who are scheduled to undergo noncardiac surgery and require patient-controlled intravenous analgesia after surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University Fist Hospital

Beijing, 100034, China

Location

Related Publications (21)

• 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.

  PMID: 26655725 BACKGROUND

• Dahan 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.

  PMID: 20010421 BACKGROUND

• Yao 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.

  PMID: 41127367 BACKGROUND

• Sessler 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.

  PMID: 40446423 BACKGROUND

• Simons 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.

  PMID: 36538359 BACKGROUND

• Ayad 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.

  PMID: 32583295 BACKGROUND

• Hammer 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.

  PMID: 34351590 BACKGROUND

• Viscusi 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.

  PMID: 30881102 BACKGROUND

• Singla 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.

  PMID: 31162798 BACKGROUND

• Markham A. Oliceridine: First Approval. Drugs. 2020 Nov;80(16):1739-1744. doi: 10.1007/s40265-020-01414-9.

  PMID: 33025536 BACKGROUND

• Ramachandran 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.

  PMID: 21570616 BACKGROUND

• Gupta 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.

  PMID: 30552274 BACKGROUND

• Cozowicz 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.

  PMID: 29958218 BACKGROUND

• Turan 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.

  PMID: 26010491 BACKGROUND

• Messineo 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.

  PMID: 39244884 BACKGROUND

• Jungquist CR, Quinlan-Colwell A, Vallerand A, Carlisle HL, Cooney M, Dempsey SJ, Dunwoody D, Maly A, Meloche K, Meyers A, Sawyer J, Singh N, Sullivan D, Watson C, Polomano RC. American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-Induced Advancing Sedation and Respiratory Depression: Revisions. Pain Manag Nurs. 2020 Feb;21(1):7-25. doi: 10.1016/j.pmn.2019.06.007. Epub 2019 Jul 31.

  PMID: 31377031 BACKGROUND

• Shafi S, Collinsworth AW, Copeland LA, Ogola GO, Qiu T, Kouznetsova M, Liao IC, Mears N, Pham AT, Wan GJ, Masica AL. Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System. JAMA Surg. 2018 Aug 1;153(8):757-763. doi: 10.1001/jamasurg.2018.1039.

  PMID: 29799927 BACKGROUND

• Oderda GM, Senagore AJ, Morland K, Iqbal SU, Kugel M, Liu S, Habib AS. Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden. J Pain Palliat Care Pharmacother. 2019 Sep-Dec;33(3-4):82-97. doi: 10.1080/15360288.2019.1668902. Epub 2019 Oct 14.

  PMID: 31609155 BACKGROUND

• Moraes EB, Brum AK, Martins JD, Antunes JM. Adverse drug events and cost components related to the use of opioids in post-operative pain: a scoping review protocol. JBI Evid Synth. 2020 Aug;18(8):1724-1730. doi: 10.11124/JBISRIR-D-19-00165.

  PMID: 32898364 BACKGROUND

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

  PMID: 32925318 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Respiratory Insufficiency

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Xue Li, MD

CONTACT

+86 18810527114; 3999165@163.com

Dong-Xin Wang, MD, PhD

CONTACT

8610 83572784; wangdongxin@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and the chief of anesthesiology department

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)