Clinical trial NCT05991830: Inflammatory Markers and Level of Cortical Hyperactivity
Official title: Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognition Disorder
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of patients \> 60 years of age who will undergo elective surgery under general anesthesia

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.

Eligibility criteria: 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

Primary outcomes:
measure: MoCA score
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Intraoperative EEG
timeFrame: Intraoperative (Day 0)
measure: Aβ40
timeFrame: Baseline (Day 0)
measure: Aβ42
timeFrame: Baseline (Day 0)
measure: GFAP™
timeFrame: Baseline (Day 0)
measure: Nf-L
timeFrame: Baseline (Day 0)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
state: RM
city: Santiago
country: Chile
facility: Hospital Clinico de la Universidad de Chile
state: RM
Study officials:
affiliation: University of Chile
name: Pedro Lobos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Antonello Penna, MD, PhD
role: STUDY_CHAIR
References: