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NOT YET RECRUITING
NCT06945926
PHASE2

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

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2025-06-01

Completion Date

2026-06-30

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China