- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372417
Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging (MACRO-AGE)
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?
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Catalina Andrea Díaz Papapietro, Anesthesiologist, MD PhD (c)
- Phone Number: +56229789405
- Email: catalinadiaz@ug.uchile.cl
Study Contact Backup
- Name: Rodrigo Gutiérrez Rojas, Assitant Professor, MD PhD
- Phone Number: +56229789405
- Email: rodrgutierrez@uchile.cl
Study Locations
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile
- Hospital Clínico Universidad de Chile
-
Contact:
- Catalina Andrea Díaz Papapietro, Anesthesiologist, PhD(c)
- Phone Number: +56229789405
- Email: catalinadiaz@ug.uchile.cl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frontal EEG alpha-band power
Time Frame: Perioperative
|
Relative EEG alpha power during surgery under general anesthesia guided by standard age-adjusted dosing
|
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-to-loss of consciousness
Time Frame: Perioperative
|
During propofol slow induction, the time required for unresponsiveness to verbal stimuli
|
Perioperative
|
|
Intraoperative anesthetic requirements
Time Frame: Perioperative
|
Total dose and infusion rate of propofol and/or sevoflurane adjusted using frontal EEG monitoring
|
Perioperative
|
|
Time to emergence
Time Frame: Perioperative
|
Time in minutes to eye opening since end of anesthesia, with verbal stimuli.
|
Perioperative
|
|
Cytokine circulating profile
Time Frame: Baseline
|
Serum inflammatory cytokine profile
|
Baseline
|
|
Monocyte/Macrophage phenotype in blood and peritoneal samples
Time Frame: Periprocedural
|
inflammatory cell Pheontype present in circulating blood (monocytes) and in peritoneal lavage and tissue samples.
|
Periprocedural
|
|
Blood-brain barrier permeability
Time Frame: Baseline
|
CSF biomarkers present: albumin, cytokines.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Antonello Penna Silva, Anesthesia Professor, MD PhD, Brain and Anesthesia Laboratory (BAL), University of Chile
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OAIC N°1538/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Center for Research and Innovation Viña Concha...Universidad Católica del MauleNot yet recruitingInflammaging | Antioxidant Status, Inflammation | Inflammation Biomarkers | Antioxidant Capabilities | Cardiometabolic Health IndicatorsChile
-
University of NebraskaNot yet recruiting
-
Central Hospital, Nancy, FranceRecruiting
-
Oral Science International Inc.AdvarraNot yet recruiting
-
University of NebraskaCompletedPeriodontal InflammationUnited States
-
University of California, DavisCompleted
-
Università degli Studi di BresciaCompletedVitreous Inflammation