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Inflammatory Markers and Level of Cortical Hyperactivity

Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05991830
Acronym
IMCH
Enrollment
20
Registered
2023-08-15
Start date
2023-08-01
Completion date
2025-09-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorder

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.

Interventions

PROCEDUREGeneral anesthesia

Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
MoCA scoreBaseline (Day 0)Score (0 to 30)

Secondary

MeasureTime frameDescription
Intraoperative EEGIntraoperative (Day 0)EEG parameters
Aβ40Baseline (Day 0)Aβ40 plasma concentration
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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026