A Phase 2 interventional study of oxytocin nasal spray in Cervical Spinal Stenosis, Thoracic Spinal Stenosis and Lumbar Spinal Stenosis, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Zhejiang University · Phase 2, Interventional, and Prevention
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 227 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
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Elderly patients undergoing orthopedic surgery under general anesthesia
Inclusion criteria:
Exclusion criteria:
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;
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.
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 surgery or discharge.
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.
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
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
Time frame: From the day of surgery to 7 days after surgery
Length of hospitalization
Recording the duration of hospitalization，Time from admission to discharge
Time frame: 1 year
Time to extubation
Time from discontinuation of anesthetic drugs to removal of endotracheal tube
Time frame: Perioperative
Time to PACU stay
Time from entering the anesthesia recovery room to leaving the anesthesia recovery room
Time frame: Perioperative
Adverse reactions related to the experimental drugs.
Adverse reactions Occasional symptoms of nasal irritation, nosebleeds, uterine bleeding, uterine hypercontractions and lacrimation
Time frame: Within 7 days of surgery
Postoperative complication
Postoperative complications such as intraoperative knowledge, lung infection, nausea and vomiting
Time frame: Perioperative, up to 1 weeks
Time of catheter removal and first time out of bed
Visiting patients daily, inquiring about their condition and keeping timely records
Time frame: Perioperative, up to 1 weeks
Plan to share: Undecided
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang University