Status:
NOT_YET_RECRUITING
The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery
Lead Sponsor:
Zhejiang University
Conditions:
Cervical Spinal Stenosis
Thoracic Spinal Stenosis
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 inf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06945926
Start Date
June 1 2025
End Date
June 30 2026
Last Update
May 25 2025
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000