NCT07372417

Brief Summary

The goal of this observational study is to determine whether macrophage/monocyte mediated inflammatory signaling contributes to reduced anesthetic requirements in older adults undergoing major abdominal surgery. The main questions it aims to answer are:

  • Is there a difference in anesthetic dosing requirements (minimum effective dose) between young and older patients undergoing major abdominal surgery?
  • How do electroencephalographic (EEG) signatures under anesthesia correlate with age and systemic inflammatory markers?
  • Is there an association between age, levels of circulating inflammatory cytokines, and monocyte/macrophage phenotypes with anesthetic requirements? If there is a comparison group: Researchers will compare older adult patients undergoing major abdominal surgery to younger adult patients undergoing major abdominal surgery to see if macrophage/monocyte-mediated inflammatory signaling influences anesthetic sensitivity and the risk of postoperative neurocognitive complications in the older population. Participants will:
  • Receive general anesthesia for major abdominal surgery, with continuous recording of anesthetic dose requirements.
  • Undergo electroencephalographic (EEG) monitoring during the anesthetic period.
  • Provide blood samples for the measurement of circulating inflammatory cytokines and the assessment of monocyte phenotypes.
  • Provide peritoneal tissue samples (collected during surgery) to evaluate tissue macrophage populations.
  • Provide cerebrospinal fluid (CSF) samples to assess biomarkers of blood-brain barrier permeability.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

November 17, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

AgingInflammationGeneral AnesthesiaAnesthetic SensitivityCytokinesAlpha OscillationsBlood Brain BarrierMonocyte phenotypemacrophage phenotype

Outcome Measures

Primary Outcomes (1)

  • Frontal EEG alpha-band power

    Relative EEG alpha power during surgery under general anesthesia guided by standard age-adjusted dosing

    Perioperative

Secondary Outcomes (6)

  • Time-to-loss of consciousness

    Perioperative

  • Intraoperative anesthetic requirements

    Perioperative

  • Time to emergence

    Perioperative

  • Cytokine circulating profile

    Baseline

  • Monocyte/Macrophage phenotype in blood and peritoneal samples

    Periprocedural

  • +1 more secondary outcomes

Study Arms (2)

Older adults

Men and women requiring abdominal surgery aged 60 years or older.

Young Adults

Men and women requiring abdominal surgery, aged 30 years or younger.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients from Hospital Clínico Universidad de Chile, in Santiago de Chile, that require elective abdominal surgery and are willing to participate in the study, meeting inclusion criteria and signing the informed consent.

You may qualify if:

  • Age between 18-30 years or over 60 years old
  • Scheduled for abdominal surgery
  • General anesthesia planned with or without spinal anesthesia
  • Able and willing to provide written informed consent.

You may not qualify if:

  • Chemotherapy or systemic corticosteroid use within the past 2 weeks.
  • Pregnancy.
  • Active sepsis or systemic infection.
  • Emergency surgery.
  • Requirement of ketamine or dexmedetomidine during the first hour of anesthesia.
  • History or diagnosis of: stroke with persistent neurological deficit, dementia, Alzheimer's disease, Huntington's disease, amyotrophic lateral sclerosis, central nervous system autoimmune disorders, systemic autoimmune diseases, or infectious diseases of the central nervous system.
  • Current treatment with immunomodulatory medications.
  • Psychiatric disorders with psychotic features.
  • Use of psychoactive or psychotropic recreational drugs within the week prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples LCR samples if available Peritoneal lavage/biopsy if available

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonello Penna Silva, Anesthesia Professor, MD PhD

    Brain and Anesthesia Laboratory (BAL), University of Chile

    STUDY CHAIR

Central Study Contacts

Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c)

CONTACT

Rodrigo Gutiérrez Rojas, Assitant Professor, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 28, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations