AgingMACRO-AGENCT07372417
Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging
An observational study of Aging and Inflammation, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging, Inflammation, Blood-Brain Barrier Permeability
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 25 Jan 2026to 15 Jun 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Current treatment with immunomodulatory medications.
- Psychiatric disorders with psychotic features.
- Use of psychoactive or psychotropic recreational drugs within the week prior to surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c) contact
Chile1 site
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan
Catalina Andrea Díaz Papapietro, Anesthesiologist, PhD(c), +56229789405, catalinadiaz@ug.uchile.cl
About this study
Official title: Role of Macrophage/Monocyte Mediated Inflammatory Response in Diminished Anesthetic Requirements During Aging
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?
Read more
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.
- Conditions
- Aging, Inflammation, Blood-Brain Barrier Permeability, Anesthesia Brain Monitor, Anesthesia Depth Monitoring, Inflammation Biomarkers
- Keywords
- Aging, Inflammation, General Anesthesia, Anesthetic Sensitivity, Cytokines, Alpha Oscillations, Blood Brain Barrier, Monocyte phenotype, macrophage phenotype
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal EEG alpha-band power
Relative EEG alpha power during surgery under general anesthesia guided by standard age-adjusted dosing
Measured: Perioperative
Secondary outcomes (6)
Time-to-loss of consciousness
During propofol slow induction, the time required for unresponsiveness to verbal stimuli
Measured: Perioperative
Intraoperative anesthetic requirements
Total dose and infusion rate of propofol and/or sevoflurane adjusted using frontal EEG monitoring
Measured: Perioperative
Time to emergence
Time in minutes to eye opening since end of anesthesia, with verbal stimuli.
Measured: Perioperative
Cytokine circulating profile
Serum inflammatory cytokine profile
Measured: Baseline
Monocyte/Macrophage phenotype in blood and peritoneal samples
inflammatory cell Pheontype present in circulating blood (monocytes) and in peritoneal lavage and tissue samples.
Measured: Periprocedural
Blood-brain barrier permeability
CSF biomarkers present: albumin, cytokines.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonello Penna Silva, Anesthesia Professor, MD PhD, Study chair, Brain and Anesthesia Laboratory (BAL), University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372417
- Sponsor's protocol ID
- OAIC N°1538/25
- Acronym
- MACRO-AGE
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Macrophage/Monocyte Mediated Inflammatory Response in Diminished Anesthetic Requirements During Aging
- ClinicalTrials.gov ID
- NCT07372417
- Acronym / sponsor ID
- MACRO-AGE / OAIC N°1538/25
- Conditions
- Aging, Inflammation, Blood-Brain Barrier Permeability, Anesthesia Brain Monitor, Anesthesia Depth Monitoring, Inflammation Biomarkers
- Keywords
- Aging, Inflammation, General Anesthesia, Anesthetic Sensitivity, Cytokines, Alpha Oscillations, Blood Brain Barrier, Monocyte phenotype
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frontal EEG alpha-band power
Time frame: Perioperative
Relative EEG alpha power during surgery under general anesthesia guided by standard age-adjusted dosing
6 secondary outcomes
Time-to-loss of consciousness
Time frame: Perioperative
Intraoperative anesthetic requirements
Time frame: Perioperative
Time to emergence
Time frame: Perioperative
Cytokine circulating profile
Time frame: Baseline
Monocyte/Macrophage phenotype in blood and peritoneal samples
Time frame: Periprocedural
Blood-brain barrier permeability
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c) contact
Antonello Penna Silva, Anesthesia Professor, MD PhD study chair
Brain and Anesthesia Laboratory (BAL), University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Inflammation, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c) (+56229789405, catalinadiaz@ug.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frontal EEG alpha-band power (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.