The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery
- Conditions
- Cervical Spinal StenosisFemoral Head NecrosisThoracic Spinal StenosisRotator Cuff InjuryLumbar Spinal StenosisSpinal TraumaKnee Joint Injury
- Interventions
- Registration Number
- NCT06945926
- Lead Sponsor
- Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳HangZhou, Zhejiang, China