The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery
NCT ID: NCT06945926
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2025-06-01
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Investigators conduct a prospective clinical study on geriatric orthopedic surgery patients to investigate the effect of oxytocin nasal spray on the prevention of postoperative delirium in geriatric orthopedic surgery. Cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia. Before the end of surgery, the Investigators administered oxytocin nasal spray (Oxytocin) that was 3 sprays in each nostril (4 IU each) for a total of 24 IU. Beginning 1 day postoperatively, administer 24 IU of oxytocin nasal spray 2 times/day in the morning and in the evening. Until 7 days after surgery or discharge. The sample size are 77 cases in phase I and 143 cases in phase 2, total 220 cases.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
NCT04216615
Elderly Patients Undergoing Surgery During Perioperative Period
NCT07314762
Postoperative Delirium in the Post-anesthesia Care Unit
NCT06318364
The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery
NCT06964893
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
NCT05068180
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients
Cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia.Before the end of anesthesia, the experimenter administered oxytocin nasal spray (Oxytocin) that was 3 sprays in each nostril (4 IU each) for a total of 24 IU. Beginning 1 day postoperatively, administer 24 IU of oxytocin nasal spray 2 times/day in the morning and 24 IU in the evening.Until 7 days after surgery or discharge.
oxytocin nasal spray
Cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia.Before the end of anesthesia, the experimenter administered oxytocin nasal spray (Oxytocin) that was 3 sprays in each nostril (4 IU each) for a total of 24 IU. Beginning 1 day postoperatively, administer 24 IU of oxytocin nasal spray 2 times/day in the morning and 24 IU in the evening.Until 7 days after surgery or discharge.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
oxytocin nasal spray
Cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia.Before the end of anesthesia, the experimenter administered oxytocin nasal spray (Oxytocin) that was 3 sprays in each nostril (4 IU each) for a total of 24 IU. Beginning 1 day postoperatively, administer 24 IU of oxytocin nasal spray 2 times/day in the morning and 24 IU in the evening.Until 7 days after surgery or discharge.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who were to undergo elective orthopedic surgery under general anesthesia with tracheal intubation;
3. ASA class I-III;
4. Estimated duration of surgery ≥ 1 hour; (5) The patient himself/herself or his/her legal representative;
5. Informed consent from the patient or legal representative;
6. Proficiency in the use of Chinese language for communication.
Exclusion Criteria
2. Oxytocin allergy;
3. Patients with previous psychiatric and neurological disorders, such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease.
Goldson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, and so on;
4. Pregnant and lactating women
5. Patients with severe hepatic insufficiency (Child-Pugh class C);
6. patients with severe renal insufficiency (dialysis is required before surgery)
7. Severe heart failure (METS\<4);
8. Preoperative inability to communicate (coma or dementia);
9. Severe preoperative blindness, deafness, or inability to understand Mandarin to complete preoperative delirium screening;
10. Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery;
11. Patients who are scheduled for 2 surgeries within 7 days of surgery;
12. Patients with bone malignancy
13. Currently participating in other clinical trials.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Diansan Su
Chair of the Department of Anesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
DiSan Head of Anesthesiology, PhD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shanshan Xu, master
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Sawares A, Olver J, Morcos M, Norman T. Oxytocin in old age psychiatry: A systematic review of the safety of using intranasal oxytocin in older adults. Australas Psychiatry. 2025 Feb;33(1):33-44. doi: 10.1177/10398562241291335. Epub 2024 Oct 30.
MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23.
Spengler FB, Schultz J, Scheele D, Essel M, Maier W, Heinrichs M, Hurlemann R. Kinetics and Dose Dependency of Intranasal Oxytocin Effects on Amygdala Reactivity. Biol Psychiatry. 2017 Dec 15;82(12):885-894. doi: 10.1016/j.biopsych.2017.04.015. Epub 2017 May 10.
Wang D, Yan X, Li M, Ma Y. Neural substrates underlying the effects of oxytocin: a quantitative meta-analysis of pharmaco-imaging studies. Soc Cogn Affect Neurosci. 2017 Oct 1;12(10):1565-1573. doi: 10.1093/scan/nsx085.
Sarahian N, Khodagholi F, Valian N, Ahmadiani A. Interplay of MeCP2/REST/Synaptophysin-BDNF and intranasal oxytocin influence on Abeta-induced memory and cognitive impairments. Behav Brain Res. 2025 Jan 5;476:115235. doi: 10.1016/j.bbr.2024.115235. Epub 2024 Sep 3.
Jiang J, Zou Y, Xie C, Yang M, Tong Q, Yuan M, Pei X, Deng S, Tian M, Xiao L, Gong Y. Oxytocin alleviates cognitive and memory impairments by decreasing hippocampal microglial activation and synaptic defects via OXTR/ERK/STAT3 pathway in a mouse model of sepsis-associated encephalopathy. Brain Behav Immun. 2023 Nov;114:195-213. doi: 10.1016/j.bbi.2023.08.023. Epub 2023 Aug 28.
Bowen MT. Does peripherally administered oxytocin enter the brain? Compelling new evidence in a long-running debate. Pharmacol Res. 2019 Aug;146:104325. doi: 10.1016/j.phrs.2019.104325. Epub 2019 Jun 21. No abstract available.
Smith AS, Korgan AC, Young WS. Oxytocin delivered nasally or intraperitoneally reaches the brain and plasma of normal and oxytocin knockout mice. Pharmacol Res. 2019 Aug;146:104324. doi: 10.1016/j.phrs.2019.104324. Epub 2019 Jun 22.
Lee MR, Shnitko TA, Blue SW, Kaucher AV, Winchell AJ, Erikson DW, Grant KA, Leggio L. Labeled oxytocin administered via the intranasal route reaches the brain in rhesus macaques. Nat Commun. 2020 Jun 3;11(1):2783. doi: 10.1038/s41467-020-15942-1.
Lee MR, Scheidweiler KB, Diao XX, Akhlaghi F, Cummins A, Huestis MA, Leggio L, Averbeck BB. Oxytocin by intranasal and intravenous routes reaches the cerebrospinal fluid in rhesus macaques: determination using a novel oxytocin assay. Mol Psychiatry. 2018 Jan;23(1):115-122. doi: 10.1038/mp.2017.27. Epub 2017 Mar 14.
Quintana DS, Westlye LT, Alnaes D, Rustan OG, Kaufmann T, Smerud KT, Mahmoud RA, Djupesland PG, Andreassen OA. Low dose intranasal oxytocin delivered with Breath Powered device dampens amygdala response to emotional stimuli: A peripheral effect-controlled within-subjects randomized dose-response fMRI trial. Psychoneuroendocrinology. 2016 Jul;69:180-8. doi: 10.1016/j.psyneuen.2016.04.010. Epub 2016 Apr 22.
Chang SW, Barter JW, Ebitz RB, Watson KK, Platt ML. Inhaled oxytocin amplifies both vicarious reinforcement and self reinforcement in rhesus macaques (Macaca mulatta). Proc Natl Acad Sci U S A. 2012 Jan 17;109(3):959-64. doi: 10.1073/pnas.1114621109. Epub 2012 Jan 3.
Kang YS, Park JH. Brain uptake and the analgesic effect of oxytocin--its usefulness as an analgesic agent. Arch Pharm Res. 2000 Aug;23(4):391-5. doi: 10.1007/BF02975453.
Burkner PC, Williams DR, Simmons TC, Woolley JD. Intranasal Oxytocin May Improve High-Level Social Cognition in Schizophrenia, But Not Social Cognition or Neurocognition in General: A Multilevel Bayesian Meta-analysis. Schizophr Bull. 2017 Oct 21;43(6):1291-1303. doi: 10.1093/schbul/sbx053.
Leppanen J, Ng KW, Tchanturia K, Treasure J. Meta-analysis of the effects of intranasal oxytocin on interpretation and expression of emotions. Neurosci Biobehav Rev. 2017 Jul;78:125-144. doi: 10.1016/j.neubiorev.2017.04.010. Epub 2017 Apr 30.
Shahrestani S, Kemp AH, Guastella AJ. The impact of a single administration of intranasal oxytocin on the recognition of basic emotions in humans: a meta-analysis. Neuropsychopharmacology. 2013 Sep;38(10):1929-36. doi: 10.1038/npp.2013.86. Epub 2013 Apr 10.
Huffmeijer R, van Ijzendoorn MH, Bakermans-Kranenburg MJ. Ageing and oxytocin: a call for extending human oxytocin research to ageing populations--a mini-review. Gerontology. 2013;59(1):32-9. doi: 10.1159/000341333. Epub 2012 Aug 24.
Jesso S, Morlog D, Ross S, Pell MD, Pasternak SH, Mitchell DG, Kertesz A, Finger EC. The effects of oxytocin on social cognition and behaviour in frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2493-501. doi: 10.1093/brain/awr171. Epub 2011 Aug 22.
Plessow F, Marengi DA, Perry SK, Felicione JM, Franklin R, Holmes TM, Holsen LM, Makris N, Deckersbach T, Lawson EA. Effects of Intranasal Oxytocin on the Blood Oxygenation Level-Dependent Signal in Food Motivation and Cognitive Control Pathways in Overweight and Obese Men. Neuropsychopharmacology. 2018 Feb;43(3):638-645. doi: 10.1038/npp.2017.226. Epub 2017 Sep 20.
Boll S, Almeida de Minas AC, Raftogianni A, Herpertz SC, Grinevich V. Oxytocin and Pain Perception: From Animal Models to Human Research. Neuroscience. 2018 Sep 1;387:149-161. doi: 10.1016/j.neuroscience.2017.09.041. Epub 2017 Sep 28.
van Zuiden M, Frijling JL, Nawijn L, Koch SBJ, Goslings JC, Luitse JS, Biesheuvel TH, Honig A, Veltman DJ, Olff M. Intranasal Oxytocin to Prevent Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial in Emergency Department Patients. Biol Psychiatry. 2017 Jun 15;81(12):1030-1040. doi: 10.1016/j.biopsych.2016.11.012. Epub 2016 Dec 8.
Moerkerke M, Daniels N, Tibermont L, Tang T, Evenepoel M, Van der Donck S, Debbaut E, Prinsen J, Chubar V, Claes S, Vanaudenaerde B, Willems L, Steyaert J, Boets B, Alaerts K. Chronic oxytocin administration stimulates the oxytocinergic system in children with autism. Nat Commun. 2024 Jan 2;15(1):58. doi: 10.1038/s41467-023-44334-4.
Sikich L, Kolevzon A, King BH, McDougle CJ, Sanders KB, Kim SJ, Spanos M, Chandrasekhar T, Trelles MDP, Rockhill CM, Palumbo ML, Witters Cundiff A, Montgomery A, Siper P, Minjarez M, Nowinski LA, Marler S, Shuffrey LC, Alderman C, Weissman J, Zappone B, Mullett JE, Crosson H, Hong N, Siecinski SK, Giamberardino SN, Luo S, She L, Bhapkar M, Dean R, Scheer A, Johnson JL, Gregory SG, Veenstra-VanderWeele J. Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder. N Engl J Med. 2021 Oct 14;385(16):1462-1473. doi: 10.1056/NEJMoa2103583.
Striepens N, Kendrick KM, Maier W, Hurlemann R. Prosocial effects of oxytocin and clinical evidence for its therapeutic potential. Front Neuroendocrinol. 2011 Oct;32(4):426-50. doi: 10.1016/j.yfrne.2011.07.001. Epub 2011 Jul 23.
Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615.
Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
Scicutella A. The pharmacotherapeutic management of postoperative delirium: an expert update. Expert Opin Pharmacother. 2020 Jun;21(8):905-916. doi: 10.1080/14656566.2020.1738388. Epub 2020 Mar 11.
Alrawashdeh W, Eschweiler J, Migliorini F, El Mansy Y, Tingart M, Rath B. Effectiveness of total knee arthroplasty rehabilitation programmes: A systematic review and meta-analysis. J Rehabil Med. 2021 Jun 2;53(6):jrm00200. doi: 10.2340/16501977-2827.
Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.
Qureshi O, Arthur ME. Recent advances in predicting, preventing, and managing postoperative delirium. Fac Rev. 2023 Jul 28;12:19. doi: 10.12703/r/12-19. eCollection 2023.
Li T, Li J, Yuan L, Wu J, Jiang C, Daniels J, Mehta RL, Wang M, Yeung J, Jackson T, Melody T, Jin S, Yao Y, Wu J, Chen J, Smith FG, Lian Q; RAGA Study Investigators. Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial. JAMA. 2022 Jan 4;327(1):50-58. doi: 10.1001/jama.2021.22647.
Heymann A, Radtke F, Schiemann A, Lutz A, MacGuill M, Wernecke KD, Spies C. Delayed treatment of delirium increases mortality rate in intensive care unit patients. J Int Med Res. 2010 Sep-Oct;38(5):1584-95. doi: 10.1177/147323001003800503.
Milisen K, Van Grootven B, Hermans W, Mouton K, Al Tmimi L, Rex S, Detroyer E. Is preoperative anxiety associated with postoperative delirium in older persons undergoing cardiac surgery? Secondary data analysis of a randomized controlled trial. BMC Geriatr. 2020 Nov 18;20(1):478. doi: 10.1186/s12877-020-01872-6.
Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
Park SK, Lim T, Cho H, Yoon HK, Lee HJ, Lee JH, Yoo S, Kim JT, Kim WH. Comparative effectiveness of pharmacological interventions to prevent postoperative delirium: a network meta-analysis. Sci Rep. 2021 Jun 7;11(1):11922. doi: 10.1038/s41598-021-91314-z.
Meagher D. Motor subtypes of delirium: past, present and future. Int Rev Psychiatry. 2009 Feb;21(1):59-73. doi: 10.1080/09540260802675460.
Olin K, Eriksdotter-Jonhagen M, Jansson A, Herrington MK, Kristiansson M, Permert J. Postoperative delirium in elderly patients after major abdominal surgery. Br J Surg. 2005 Dec;92(12):1559-64. doi: 10.1002/bjs.5053.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZJU2025C045
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.