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The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery
Plain-language guide to NCT06945926: phase 2 interventional trial of Oxytocin, 227 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06945926
- Phase
- phase 2
- Status
- completed
- Start
- 2025-06-01
- Completion (planned or actual)
- 2026-05-25
- Participants
- 227 (actual)
- Design
- na, open label (everyone knows who gets what), prevention
- Conditions studied
- Cervical Spinal Stenosis; Thoracic Spinal Stenosis; Lumbar Spinal Stenosis; Rotator Cuff Injury; Femoral Head Necrosis; Spinal Trauma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Oxytocin.
Postoperative delirium is a delirium that occurs within 7 days after surgery or before hospital discharge.
The incidence of postoperative delirium in geriatric orthopedics is high.
It had 1 arm (groups): Oxytocin nasal spray given to geriatric orthopedic general anesthesia patients (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 227 actual participants took part.
It was open to people of any sex aged from 65 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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;.
The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: 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.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2025-06-01 with completion listed for 2026-05-25.
It ran at 1 site in China.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Incidence of postoperative delirium within 7 days after surgery.
It also tracked 2 secondary outcomes, for example The severity of postoperative delirium and Length of hospitalization.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Oxytocin in 227 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.