Cervical Spinal Stenosis, Femoral Head Necrosis, Knee Joint Injury, Lumbar Spinal Stenosis, Rotator Cuff Injury, Spinal Trauma, Thoracic Spinal Stenosis
Conditions
Keywords
Postoperative delirium, elderly orthopedics, oxytocin nasal spray
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 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
DRUGoxytocin 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.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium within 7 days after surgery. | From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The severity of postoperative delirium | From the day of surgery to 7 days after surgery | 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 |
| Length of hospitalization | 1 year | Recording the duration of hospitalization，Time from admission to discharge |
Countries
China
Outcome results
None listed