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

NCT06945926 | Not Yet Recruiting Phase 2

• 1 other identifier: ZJU2025C045
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Postoperative delirium; elderly orthopedics; oxytocin nasal spray

Outcome Measures

Primary Outcomes (1)

• 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.

  From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon

Secondary Outcomes (2)

• The severity of postoperative delirium

  From the day of surgery to 7 days after surgery

• Length of hospitalization

  1 year

Other Outcomes (5)

• Time to extubation

  Perioperative

• Time to PACU stay

  Perioperative

• Adverse reactions related to the experimental drugs.

  Within 7 days of surgery

Study Arms (1)

Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients

EXPERIMENTAL

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

Interventions

oxytocin nasal spray DRUG

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.

Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

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MeSH Terms

Conditions

Spinal Stenosis; Rotator Cuff Injuries; Emergence Delirium

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

DiSan Head of Anesthesiology, PhD

CONTACT

86+18616514088; 184872238@qq.com

Shanshan Xu, Master

CONTACT

86+057187236169; shanshan_xu2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-03

Locations

CN (1)