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

May 23, 2025 updated by: Diansan Su, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: DiSan Head of Anesthesiology, PhD
  • Phone Number: 86+18758189796 86+18616514088
  • Email: 184872238@qq.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • HangZhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Shanshan Xu, master
          • Phone Number: 86+18758189796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the day of surgery to 7 days after surgery
Length of hospitalization
Time Frame: 1 year
Recording the duration of hospitalization，Time from admission to discharge
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to extubation
Time Frame: Perioperative
Time from discontinuation of anesthetic drugs to removal of endotracheal tube
Perioperative
Time to PACU stay
Time Frame: Perioperative
Time from entering the anesthesia recovery room to leaving the anesthesia recovery room
Perioperative
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
Within 7 days of surgery
Postoperative complication
Time Frame: Perioperative, up to 1 weeks
Postoperative complications such as intraoperative knowledge, lung infection, nausea and vomiting
Perioperative, up to 1 weeks
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
Perioperative, up to 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025C045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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