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

Launched by ZHEJIANG UNIVERSITY · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a nasal spray containing oxytocin can help prevent delirium in elderly patients after orthopedic surgery. Delirium is a temporary state of confusion that can happen within a week after surgery and can lead to other health problems, especially in older adults. The researchers are specifically looking at patients aged 65 and older who are undergoing elective orthopedic surgeries, like knee or spinal surgeries, and who are generally healthy enough for surgery.

If you or a family member is considering participating, you would need to be at least 65 years old and scheduled for a specific type of orthopedic surgery. The trial involves receiving oxytocin nasal spray before and after surgery, and the researchers will monitor your health for a week after the procedure. It’s important to note that certain conditions, like having a serious mental health issue or allergies to oxytocin, would prevent someone from joining the study. The trial is not yet recruiting participants, but it aims to gather important information that could improve care for elderly surgical patients in the future.

Gender

ALL

Eligibility criteria

• • Elderly patients undergoing orthopedic surgery under general anesthesia
• Inclusion criteria:
• • 1. Age ≥ 65 years;
• • 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:
• • 1. Nasal cavity occupation, patients with fillers in the nose
• • 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.