MedPath

Inflammatory Markers and Level of Cortical Hyperactivity

Recruiting
Conditions
Cognition Disorder
Interventions
Procedure: General anesthesia
Registration Number
NCT05991830
Lead Sponsor
University of Chile
Brief Summary

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease. In this project we will seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6 and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery.

Detailed Description

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). It is now known that markers of damage begin decades before symptoms can be detected, at the stage called preclinical early AD, which progresses inexorably to mild cognitive impairment and ends in severe Alzheimer's dementia. Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease, however, they have not been directly related in a clinical context. In this project we will seek to relate the levels of the proinflammatory cytokines IL-1beta, IL-6 and TNF-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery. The main goal of this project is to determine the levels of inflammatory markers and cortical hyperactivity in older adults. Methodology: the project is an exploratory observational study of a prospective cohort of patients \> 60 years of age who will undergo elective surgery under general anesthesia. In the preoperative period, peripheral venous blood samples will be obtained and stored at -80 ° C and then analyzed by the SIMOA® analyzer, fully automated and digital equipment for performing immunoassays, based on SIMOA® technology, which provide an ultrasensitive signal and / or measurement up to 1000 times greater than conventional immunoassays (in the femtomolar range) of proteins. On the other hand, EEG signal at 128 Hz and other variables from BIS® monitor will be recorded to determine the level of cortical hyperactivity.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  1. Adults over 60 years of age undergoing elective surgery
  2. Able to understand and sign an informed consent form
Exclusion Criteria
  1. Diagnosis of other neurological pathologies
  2. No active acute or chronic decompensated diseases
  3. No severe psychiatric illnesses
  4. Propofol allergy

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Older adults > 60 yearsGeneral anesthesia-
Primary Outcome Measures
NameTimeMethod
MoCA scoreBaseline (Day 0)

Score (0 to 30)

Secondary Outcome Measures
NameTimeMethod
Aβ42Baseline (Day 0)

Aβ42 plasma concentration

GFAP™Baseline (Day 0)

Glial Fibrillary Acidic Protein (GFAP™) plasma concentration

Nf-LBaseline (Day 0)

Neurofilament light (Nf-L) plasma concentration

Intraoperative EEGIntraoperative (Day 0)

EEG parameters

Aβ40Baseline (Day 0)

Aβ40 plasma concentration

Trial Locations

Locations (2)

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

🇨🇱

Santiago, RM, Chile

Hospital Clinico de la Universidad de Chile

🇨🇱

Santiago, RM, Chile

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