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Cervical Spinal StenosisPhase 2NCT06945926

The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery

A Phase 2 study testing oxytocin nasal spray in people with Cervical Spinal Stenosis and Thoracic Spinal Stenosis, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative delirium is a delirium that occurs within 7 days after surgery or before hospital discharge. It has been shown that combined POD can increase the incidence of postoperative pulmonary infections, deep vein thrombosis and decubitus ulcers, and increase the incidence of disability and mortality. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
oxytocin nasal spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
1 siteChina
Study dates
1 Jun 2025to 2 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65 years;
  • Patients who were to undergo elective orthopedic surgery under general anesthesia with tracheal intubation;
  • ASA class I-III;
  • Estimated duration of surgery ≥ 1 hour; (5) The patient himself/herself or his/her legal representative;
  • Informed consent from the patient or legal representative;
  • Proficiency in the use of Chinese language for communication.

Who cannot join

  • Nasal cavity occupation, patients with fillers in the nose
  • Oxytocin allergy;
  • 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;
  • Pregnant and lactating women
  • Patients with severe hepatic insufficiency (Child-Pugh class C);
Show all 14Show fewer
  • patients with severe renal insufficiency (dialysis is required before surgery)
  • Severe heart failure (METS<4);
  • Preoperative inability to communicate (coma or dementia);
  • Severe preoperative blindness, deafness, or inability to understand Mandarin to complete preoperative delirium screening;
  • Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery;
  • Patients who are scheduled for 2 surgeries within 7 days of surgery;
  • Patients with bone malignancy
  • Currently participating in other clinical trials.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery：Two-Stage Designs for Phase II Clinical Trials

Postoperative delirium is a delirium that occurs within 7 days after surgery or before hospital discharge. It has been shown that combined POD can increase the incidence of postoperative pulmonary infections, deep vein thrombosis and decubitus ulcers, and increase the incidence of disability and mortality. The incidence of postoperative delirium in geriatric orthopedics is high.

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.

Being tested
oxytocin nasal spray
Keywords
Postoperative delirium, elderly orthopedics, oxytocin nasal spray
Medical subject headings
Spinal Stenosis, Rotator Cuff Injuries, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxytocin nasal sprayDrug

    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.

Study groups in NCT06945926
Study groupRoleWhat they receive
Oxytocin nasal spray given to geriatric orthopedic general anesthesia patientsExperimentalCases 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.
Receives: Drug: oxytocin nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative delirium within 7 days after surgery.

    In the anesthesia recovery room, the CAM-ICU(The Confusion Assessment method for the ICU ) scale was performed 30 min after extubation. Postoperative delirium was measured by the 3D-CAM (The 3-Minute Diagnostic Confusion Assessment Method)scale from postoperative day 1 until postoperative day 7 or before discharge from the hospital. The CAM scale includes four major features: 1. Acute onset or fluctuating changes in condition 2. Inattention 3. Confusion 4. Changes in level of consciousness. Delirium is diagnosed when features 1 and 2 are positive at the same time, and/or features 3 and 4 are positive.

    Measured: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon

Secondary outcomes (2)

  1. The severity of postoperative delirium

    If the patient develops delirium, assess the severity with the MDAS( Memory Disorder Assessment Scale).The total score is 30 points, and the higher the score, the greater the degree of delirium

    Measured: From the day of surgery to 7 days after surgery

  2. Length of hospitalization

    Recording the duration of hospitalization，Time from admission to discharge

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start1 Jun 2025
  3. Primary completion25 May 2026
  4. Study completion2 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945926
Sponsor's protocol ID
ZJU2025C045
Status last verified
Aug 2026
First submitted
8 Apr 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39474844

  • 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.

    PubMed 21429671

  • 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.

    PubMed 28629540

  • 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.

    PubMed 29048602

  • 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.

    PubMed 39236931

  • 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.

    PubMed 37648002

  • 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.

    PubMed 31233803

  • 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.

    PubMed 31238093

  • 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.

    PubMed 32494001

  • 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.

    PubMed 28289281

  • 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.

    PubMed 27107209

  • 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.

    PubMed 22215593

  • 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.

    PubMed 10976589

  • 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.

    PubMed 28586471

  • 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.

    PubMed 28467893

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxytocin nasal spray in people with Cervical Spinal Stenosis and Thoracic Spinal Stenosis, run by Zhejiang University 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 20 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative delirium within 7 days after surgery. (time frame: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon). 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 NCT06945926, which also lists 37 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 20 Aug 2026.

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