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Search / Trial NCT06709482

Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index

Launched by MEDICAL UNIVERSITY INNSBRUCK · Nov 27, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Postoperative Delirium Inflammation Heart Rate Variability

ClinConnect Summary

This clinical trial is looking to understand if changes in heart rate can help predict the likelihood of developing postoperative delirium, which is a state of confusion that some patients experience after surgery. Specifically, the study will examine how the balance between two parts of the nervous system—one that speeds up the heart rate and one that slows it down—affects the chances of experiencing delirium after surgery. The researchers want to find out if patients with higher activity in the part of the nervous system that speeds things up are more likely to have this confusion compared to those whose nervous system is calmer.

To be eligible for this trial, participants must be over 50 years old and scheduled for certain types of surgeries, like orthopedic or trauma surgeries, that will require general anesthesia for at least an hour. However, individuals who already have certain conditions, such as a history of delirium before surgery or severe heart or brain disorders, will not be able to participate. If someone joins the study, they can expect to be monitored closely to see how their heart rate responds during and after surgery and how it relates to their cognitive state. This trial is currently not yet recruiting participants, but it aims to gather important information that could help improve care for patients undergoing surgery in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. \> 50 years of age
  • 2. Scheduled for elective moderate to major risk traumatology or orthopedic surgery (excluding spine surgery) and anticipated duration of general anaesthesia ≥ 60 minutes.
  • Exclusion Criteria:
  • 1. Delirium before surgery.
  • 2. Patients with emergency surgery
  • 3. Contraindication to general anesthesia
  • 4. ASA ≥ 4.
  • 5. Terminal disease.
  • 6. h/o documented dementia, MoCA Score \<18
  • 7. h/o atrial fibrillation
  • 8. h/o Parkinson´s disease / Multiple system atrophy / Pure autonomic failure
  • 9. h/o autonomic dysfunction (neurogenic autonomic dysfunction)
  • 10. h/o stroke/intracerebral hemorrhage
  • 11. Cerebral neoplasia
  • 12. h/o chronic central nervous disorder (e.g. multiple sclerosis)
  • 13. Major Depression
  • 14. Language, vision, or hearing impairments that may compromise delirium or cognitive assessments.
  • 15. h/o malignant hyperthermia
  • 16. h/o structural muscle disease
  • 17. h/o substance abuse
  • 18. h/o polyneuropathy
  • 19. h/o psychiatric disease
  • 20. h/o or current substance use disorder (DSM V)

About Medical University Innsbruck

The Medical University of Innsbruck is a leading academic institution dedicated to advancing healthcare through innovative research and clinical excellence. Situated in the heart of the Austrian Alps, it combines a rich tradition of medical education with cutting-edge scientific inquiry. As a prominent sponsor of clinical trials, the university focuses on a broad spectrum of medical fields, emphasizing the translation of research findings into practical applications for patient care. With a commitment to ethical standards and rigorous methodologies, the Medical University of Innsbruck strives to enhance treatment options and improve health outcomes globally through its collaborative efforts in clinical research.

Locations

Patients applied

0 patients applied

Trial Officials

Christine Eckhardt, MD, PhD

Principal Investigator

Medical University Innsbruck

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported