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Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging (MACRO-AGE)

U

University of Chile

Status

Not yet enrolling

Conditions

Inflammaging
Aging
Inflammation Biomarkers
Inflammation
Blood-Brain Barrier Permeability
Monocyte
Anesthesia Brain Monitor
Anesthesia Depth Monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT07372417
OAIC N°1538/25

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

60 participants in 2 patient groups

Older adults
Description:
Men and women requiring abdominal surgery aged 60 years or older.
Young Adults
Description:
Men and women requiring abdominal surgery, aged 30 years or younger.

Trial contacts and locations

1

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Central trial contact

Rodrigo Gutiérrez Rojas, Assitant Professor, MD PhD; Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c)

Data sourced from clinicaltrials.gov

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