{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T06:04:52Z","timestamp":1780639492045,"version":"3.54.1"},"reference-count":28,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T00:00:00Z","timestamp":1780617600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"\n Background<\/jats:title>\n \n Postoperative nausea and vomiting (PONV) is a prevalent adverse event following bimaxillary orthognathic surgery, with opioids being a significant contributing factor. Oliceridine, a G protein-biased\n \u03bc<\/jats:italic>\n -opioid receptor agonist, reduces activation of the\n \u03b2<\/jats:italic>\n -arrestin pathway and may decrease gastrointestinal adverse events relative to traditional opioids. This study aimed to evaluate the efficacy and safety of oliceridine relative to sufentanil for postoperative patient-controlled intravenous analgesia (PCIA) in this population, with a particular emphasis on PONV.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This prospective, double-blind, randomized controlled exploratory trial was conducted at the Peking University School and Hospital of Stomatology from March to August 2025. A total of 100 eligible patients (ASAI-II, BMI 18\u201324\u202fkg\/m\n 2<\/jats:sup>\n , aged 18\u201360\u202fyears) were randomly assigned in a 1:1 ratio to receive either oliceridine (0.25\u202fmg\/kg combined with tropisetron 10\u202fmg, designated as Group O) or sufentanil (1.25\u202f\u03bcg\/kg combined with tropisetron 10\u202fmg, designated as Group S) via patient-controlled intravenous analgesia (PCIA), which included a 2\u202fmL\/h background infusion, 0.5\u202fmL bolus, 15-min lockout interval. All participants were administered multimodal antiemetic prophylaxis and standardized general anesthesia. The primary outcome measure was the incidence of PONV within 72\u202fh. Secondary outcome measures included the severity of PONV, the use of rescue antiemetics, postoperative pain scores assessed using an 11-point numerical rating scale (NRS), and the occurrence of adverse events. Statistical analyses were conducted using SPSS version 26.0, with a significance threshold set at\n p<\/jats:italic>\n &lt;\u202f0.05.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The baseline characteristics were comparable between the groups. The incidence of PONV within 72\u202fh was lower in Group O compared to Group S (40.0% vs. 50.0%; odds ratio [OR]\u202f=\u202f0.67, 95% confidence interval [CI]: 0.30\u20131.47;\n p\u202f=<\/jats:italic>\n 0.315). Similarly, the incidences of moderate-to-severe PONV (26.0% vs. 36.0%; OR\u202f=\u202f0.59, 95% CI: 0.28\u20131.25;\n p<\/jats:italic>\n =\u202f0.108) and the requirement for rescue antiemetics (20.0% vs. 34.0%; OR\u202f=\u202f0.49, 95% CI: 0.20\u20131.20;\n p\u202f=<\/jats:italic>\n 0.115) were lower in Group O. However, none of these differences reached statistically significance. A repeated-measures analysis of variance (ANOVA) for moderate-to-severe postoperative pain revealed a significant effect of time (\n F<\/jats:italic>\n =\u202f17.189,\n p<\/jats:italic>\n &lt;\u202f0.001) but no significant group-time interaction (\n p<\/jats:italic>\n =\u202f0.142). No serious adverse events, such as respiratory depression or hypotension, were reported in either group, and the incidence of dizziness was similar between the groups (22% vs. 24%,\n p<\/jats:italic>\n \u202f&gt;\u202f0.05).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Oliceridine demonstrated comparable analgesic efficacy and safety to sufentanil, exhibiting numerically lower, albeit not statistically significant, differences in postoperative nausea and vomiting (PONV) and the use of rescue antiemetics. Considering the exploratory nature of this study and the determination of the sample size based primarily on clinical feasibility rather than statistical power, these findings should be regarded as preliminary. Further validation in larger, adequately powered trials incorporating dose-optimization designs is necessary.<\/jats:p>\n <\/jats:sec>\n \n Clinical trial registration<\/jats:title>\n \n https:\/\/www.chictr.org.cn\/showproj.html?proj=257554<\/jats:ext-link>\n , Identifier: ChiCTR2500096345.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fmed.2026.1839035","type":"journal-article","created":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T05:40:39Z","timestamp":1780638039000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of oliceridine and sufentanil in postoperative pain management for postoperative nausea and vomiting after bimaxillary orthognathic surgery: an exploratory randomized controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Yi","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guoli","family":"Xiong","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Likuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaodong","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xudong","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Peking University School and Hospital of Stomatology","place":["Beijing, China"]},{"name":"National Center of Stomatology and National Clinical Research Center for Oral Diseases","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,6,5]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"1034","DOI":"10.1177\/147323001003800330","article-title":"Documentation of post-operative nausea and vomiting in routine clinical practice","volume":"38","author":"Franck","year":"2010","journal-title":"J Int Med Res"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"1385","DOI":"10.1016\/j.joms.2006.05.024","article-title":"Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review","volume":"64","author":"Silva","year":"2006","journal-title":"J Oral Maxillofac Surg"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"745","DOI":"10.1016\/j.ijom.2015.01.006","article-title":"Postoperative nausea and vomiting following orthognathic surgery","volume":"44","author":"Phillips","year":"2015","journal-title":"Int J Oral Maxillofac Surg"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1016\/j.ijom.2019.06.016","article-title":"Predicting postoperative nausea and vomiting in patients undergoing oral and maxillofacial surgery","volume":"49","author":"Laskin","year":"2020","journal-title":"Int J Oral Maxillofac Surg"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"122","DOI":"10.1007\/s00540-021-03017-4","article-title":"Penehyclidine for prevention of postoperative nausea and vomiting following bimaxillary orthognathic surgery: a randomized, double-blind, controlled trial","volume":"36","author":"Wang","year":"2022","journal-title":"J Anesth"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"213","DOI":"10.2165\/00003495-200059020-00005","article-title":"Prevention and treatment of postoperative nausea and vomiting","volume":"59","author":"Kovac","year":"2000","journal-title":"Drugs"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"652","DOI":"10.1097\/00000539-199909000-00022","article-title":"Which clinical anesthesia outcomes are important to avoid? The perspective of patients","volume":"89","author":"Macario","year":"1999","journal-title":"Anesth Analg"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1097\/00000539-200102000-00022","article-title":"How much are patients willing to pay to avoid postoperative nausea and vomiting?","volume":"92","author":"Gan","year":"2001","journal-title":"Anesth Analg"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1016\/j.jclinane.2009.02.015","article-title":"Postoperative patient complaints: a prospective interview study of 12,276 patients","volume":"22","author":"Lehmann","year":"2010","journal-title":"J Clin Anesth"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1093\/bja\/aes276","article-title":"Evidence-based analysis of risk factors for postoperative nausea and vomiting","volume":"109","author":"Apfel","year":"2012","journal-title":"Br J Anaesth"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"8","DOI":"10.2165\/00003495-198300251-00003","article-title":"Neuropharmacology of chemotherapy-induced emesis","volume":"25","author":"Borison","year":"1983","journal-title":"Drugs"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1016\/0301-0082(89)90028-2","article-title":"Area postrema: chemoreceptor circumventricular organ of the medulla oblongata","volume":"32","author":"Borison","year":"1989","journal-title":"Prog Neurobiol"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"6043","DOI":"10.2174\/138161212803582540","article-title":"Non-analgesic effects of opioids: opioid-induced nausea and vomiting: mechanisms and strategies for their limitation","volume":"18","author":"Coluzzi","year":"2012","journal-title":"Curr Pharm Des"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"475","DOI":"10.1097\/ALN.0b013e318267ef31","article-title":"Who is at risk for postdischarge nausea and vomiting after ambulatory surgery?","volume":"117","author":"Apfel","year":"2012","journal-title":"Anesthesiology"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"659","DOI":"10.1093\/bja\/88.5.659","article-title":"Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design","volume":"88","author":"Apfel","year":"2002","journal-title":"Br J Anaesth"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"1343","DOI":"10.1213\/01.ANE.0000180204.64588.EC","article-title":"Postoperative nausea and vomiting are strongly influenced by postoperative opioid use in a dose-related manner","volume":"101","author":"Roberts","year":"2005","journal-title":"Anesth Analg"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1016\/j.bmcl.2015.12.024","article-title":"Biased agonism: an emerging paradigm in GPCR drug discovery","volume":"26","author":"Rankovic","year":"2016","journal-title":"Bioorg Med Chem Lett"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"8019","DOI":"10.1021\/jm4010829","article-title":"Structure-activity relationships and discovery of a G protein biased \u03bc opioid receptor ligand, [(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro-[4.5]decan-9-yl]ethyl})amine (TRV130), for the treatment of acute severe pain","volume":"56","author":"Chen","year":"2013","journal-title":"J Med Chem"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"5415","DOI":"10.2147\/DDDT.S525471","article-title":"Overview and prospects of the clinical application of Oliceridine","volume":"19","author":"Yi","year":"2025","journal-title":"Drug Des Devel Ther"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"927","DOI":"10.2147\/JPR.S171013","article-title":"APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the \u03bc-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy","volume":"12","author":"Viscusi","year":"2019","journal-title":"J Pain Res"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"715","DOI":"10.1111\/papr.12801","article-title":"APOLLO-2: a randomized, placebo and active-controlled phase III study investigating Oliceridine (TRV130), a G protein-biased ligand at the \u03bc-opioid receptor, for Management of Moderate to severe acute pain following abdominoplasty","volume":"19","author":"Singla","year":"2019","journal-title":"Pain Pract"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"1576154","DOI":"10.3389\/fphar.2025.1576154","article-title":"Comparison of oliceridine and sufentanil in patient\u2014controlled intravenous analgesia for post\u2014thoracoscopic nausea and vomiting: a prospective, double\u2014blind, randomized controlled trial","volume":"16","author":"Meng","year":"2025","journal-title":"Front Pharmacol"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"693","DOI":"10.1097\/00000542-199909000-00022","article-title":"A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers","volume":"91","author":"Apfel","year":"1999","journal-title":"Anesthesiology"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"111870","DOI":"10.1016\/j.jclinane.2025.111870","article-title":"Oliceridine for postoperative pain and opioid-related complications: the intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study","volume":"105","author":"Sessler","year":"2025","journal-title":"J Clin Anesth"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"1739","DOI":"10.1007\/s40265-020-01414-9","article-title":"Oliceridine: first approval","volume":"80","author":"Markham","year":"2020","journal-title":"Drugs"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1213\/ane.0000000000007816","article-title":"Fifth consensus guidelines for the Management of Postoperative Nausea and Vomiting: executive summary","author":"Gan","year":"2025","journal-title":"Anesth Analg"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"Cd012859","DOI":"10.1002\/14651858.CD012859.pub2","article-title":"Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis","volume":"10","author":"Weibel","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"941","DOI":"10.1016\/j.joms.2023.04.014","article-title":"The beneficial effect of preoperative Dexmedetomidine in controlling postoperative pain, nausea, and vomiting after orthognathic surgery: a triple-blind randomized clinical trial","volume":"81","author":"Labafchi","year":"2023","journal-title":"J Oral Maxillofac Surg"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1839035\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T05:40:40Z","timestamp":1780638040000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1839035\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,5]]},"references-count":28,"alternative-id":["10.3389\/fmed.2026.1839035"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1839035","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,5]]},"article-number":"1839035"}}