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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Pregnant and lactating women

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: Oxytocin nasal spray given to geriatric orthopedic general anesthesia patientsExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

The severity of postoperative delirium

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

Time frame
From the day of surgery to 7 days after surgery
2

Length of hospitalization

Recording the duration of hospitalization,Time from admission to discharge

Time frame
1 year

Other outcomes

1

Time to extubation

Time from discontinuation of anesthetic drugs to removal of endotracheal tube

Time frame
Perioperative
2

Time to PACU stay

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

Time frame
Perioperative
3

Adverse reactions related to the experimental drugs.

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

Time frame
Within 7 days of surgery
4

Postoperative complication

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

Time frame
Perioperative, up to 1 weeks

Sponsors and contacts

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