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NCT Number: NCT06945926

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

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.

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Key information

Conditions

Cervical Spinal Stenosis Bone Diseases Confusion Delirium Emergence Delirium Femoral Head Necrosis Knee Joint Injury Lumbar Spinal Stenosis Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rotator Cuff Injuries Rotator Cuff Injury Rupture Shoulder Injuries Signs and Symptoms Spinal Diseases Spinal Stenosis Spinal Trauma Tendon Injuries Thoracic Spinal Stenosis Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location contact

Shanshan Xu, master

CONTACT

86+18758189796

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Elderly patients undergoing orthopedic surgery under general anesthesia

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  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

    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 outcomes

  1. The severity of postoperative delirium

    Time frame: 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

  2. Length of hospitalization

    Time frame: 1 year

    Recording the duration of hospitalization，Time from admission to discharge

Other outcomes

  1. Time to extubation

    Time frame: Perioperative

    Time from discontinuation of anesthetic drugs to removal of endotracheal tube

  2. Time to PACU stay

    Time frame: Perioperative

    Time from entering the anesthesia recovery room to leaving the anesthesia recovery room

  3. Adverse reactions related to the experimental drugs.

    Time frame: Within 7 days of surgery

    Adverse reactions Occasional symptoms of nasal irritation, nosebleeds, uterine bleeding, uterine hypercontractions and lacrimation

  4. Postoperative complication

    Time frame: Perioperative, up to 1 weeks

    Postoperative complications such as intraoperative knowledge, lung infection, nausea and vomiting

  5. Time of catheter removal and first time out of bed

    Time frame: Perioperative, up to 1 weeks

    Visiting patients daily, inquiring about their condition and keeping timely records

Study contacts

Contact information is provided by the study sponsor or research team.

DiSan Head of Anesthesiology, PhD

CONTACT

[email protected]

86+18616514088 ext. 86+18758189796

Shanshan Xu, Master

CONTACT

[email protected]

86+057187236169 ext. 86+18758189796

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery：Two-Stage Designs for Phase II Clinical Trials

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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