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

NCT06709482 | Not Yet Recruiting

• 1 other identifier: EK Nr: 1061/2024
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this pilot study is to establish a correlation between perioperative heart rate variability (HRV) as an expression of the shift in the balance of the autonomic nervous system and the occurrence of postoperative inflammation and delirium. The main question it aims to answer is: Do patient with increased sympathetic nervous system activity develop postoperative delirium (POD) more often than patients with increased parasympathetic tone?

Conditions

POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE; Heart Rate Variability; Biomarkers

Keywords

postoperative delirium; inflammation; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Cognitive function at 90 days after surgery

  Structured neurocognitive assessment using the test battery.

  90 days

Secondary Outcomes (1)

• HRV and postoperative delirium

  5 days

Other Outcomes (1)

• neuro-degenerative/neuro-inflammation markers inflammatory

  90 days

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \> 50 years undergoing surgery lasting at least 60 min

You may qualify if:

• \> 50 years of age
• Scheduled for elective moderate to major risk traumatology or orthopedic surgery (excluding spine surgery) and anticipated duration of general anaesthesia ≥ 60 minutes.

You may not qualify if:

• Delirium before surgery.
• Patients with emergency surgery
• Contraindication to general anesthesia
• ASA ≥ 4.
• Terminal disease.
• h/o documented dementia, MoCA Score \<18
• h/o atrial fibrillation
• h/o Parkinson´s disease / Multiple system atrophy / Pure autonomic failure
• h/o autonomic dysfunction (neurogenic autonomic dysfunction)
• h/o stroke/intracerebral hemorrhage
• Cerebral neoplasia
• h/o chronic central nervous disorder (e.g. multiple sclerosis)
• Major Depression
• Language, vision, or hearing impairments that may compromise delirium or cognitive assessments.
• h/o malignant hyperthermia

Sponsors & Collaborators

• Medical University Innsbruck: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood, serum

MeSH Terms

Conditions

Emergence Delirium; Inflammation

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christine Eckhardt, MD, PhD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Sinner, Prof Dr MBA

CONTACT

43 (0) 512 504-0; barbara.sinner@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2024-11