Inflammatory Markers and Level of Cortical Hyperactivity (IMCH)

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

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.

Study Overview

• Status: Completed
• Conditions: Cognition Disorder
• Intervention / Treatment: Procedure: General anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 7690306
      • Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
    • Santiago, RM, Chile, 7690306
      • Hospital Clinico de la Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients > 60 years of age who will undergo elective surgery under general anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Older adults > 60 years	Procedure: General anesthesia; Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA score	Score (0 to 30)	Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative EEG	EEG parameters	Intraoperative (Day 0)
Aβ40	Aβ40 plasma concentration	Baseline (Day 0)
Aβ42	Aβ42 plasma concentration	Baseline (Day 0)
GFAP™	Glial Fibrillary Acidic Protein (GFAP™) plasma concentration	Baseline (Day 0)
Nf-L	Neurofilament light (Nf-L) plasma concentration	Baseline (Day 0)

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Pedro Lobos, PhD, University of Chile; Study Chair: Antonello Penna, MD, PhD, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Anesthesia and Analgesia; Anesthesia; Anesthesia, General
• Other Study ID Numbers: OAIC: 1311/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared based on individual requests made directly to study investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No