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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorMedical University Innsbruck

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

> 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.

Disqualifiers

Delirium before surgery.

Patients with emergency surgery

Contraindication to general anesthesia

ASA ≥ 4.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Cognitive function at 90 days after surgery

Structured neurocognitive assessment using the test battery.

Time frame
90 days

Secondary outcomes

1

HRV and postoperative delirium

Comparison of heart rate variability before, during and after anaesthesia in patients with and without POCD.

Time frame
5 days

Other outcomes

1

neuro-degenerative/neuro-inflammation markers inflammatory

Correlation of the concentration of the biomarkers S-100B (µg/L), NSE (µg/L), NfL (pg/mL), CRP (mg/L) PCT (mg/L), IL-6 (pg/mL), TNF-alpha (ng/mL), in patients with and without POD/POCD

Time frame
90 days

Locations

This trial has no locations.

Sponsors and contacts

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