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

Status

Completed

Phase

Phase 2

Enrollment

227 participants (actual)

Sponsor

Zhejiang University · Other

Design

Allocation not applicable · Open label (no masking)

Countries

1 country

China

Start

1 Jun 2025

Primary completion

25 May 2026

Completion

2 Jun 2026

First posted

27 Apr 2025

Last update posted

20 Aug 2026

Conditions

Cervical Spinal Stenosis · Thoracic Spinal Stenosis · Lumbar Spinal Stenosis · Rotator Cuff Injury · Femoral Head Necrosis · Spinal Trauma · Knee Joint Injury

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.

• Experimental

  Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients

  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.

1. Incidence of postoperative delirium within 7 days after surgery.

   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

   Registry description

   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.