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Not yet recruiting NCT06945926

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

Phase II Interventional Cervical Spinal Stenosis Thoracic Spinal Stenosis Lumbar Spinal Stenosis Rotator Cuff Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oxytocin nasal spray.
Who it may be relevant to
Registry conditions: Cervical Spinal Stenosis, Thoracic Spinal Stenosis, Lumbar Spinal Stenosis, Rotator Cuff Injury. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug 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 surger

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • The severity of postoperative delirium [Time frame: From the day of surgery to 7 days after surgery]
  • Length of hospitalization [Time frame: 1 year]

Eligibility criteria

Elderly patients undergoing orthopedic surgery under general anesthesia

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31238093

Identifiers

NCT: NCT06945926 · ZJU2025C045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗