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Clinical Trials/NCT05991830
NCT05991830
Completed
Not Applicable

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

University of Chile2 sites in 1 country20 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognition Disorder
Sponsor
University of Chile
Enrollment
20
Locations
2
Primary Endpoint
MoCA score
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
September 30, 2025
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults over 60 years of age undergoing elective surgery
  • Able to understand and sign an informed consent form

Exclusion Criteria

  • Diagnosis of other neurological pathologies
  • No active acute or chronic decompensated diseases
  • No severe psychiatric illnesses
  • Propofol allergy

Outcomes

Primary Outcomes

MoCA score

Time Frame: Baseline (Day 0)

Score (0 to 30)

Secondary Outcomes

  • Aβ42(Baseline (Day 0))
  • GFAP™(Baseline (Day 0))
  • Nf-L(Baseline (Day 0))
  • Intraoperative EEG(Intraoperative (Day 0))
  • Aβ40(Baseline (Day 0))

Study Sites (2)

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