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临床试验/NCT07372417
NCT07372417尚未招募不适用

Role of Macrophage/Monocyte Mediated Inflammatory Response in Diminished Anesthetic Requirements During Aging

University of Chile1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Frontal EEG alpha-band power

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Frontal EEG alpha-band power

时间窗: Perioperative

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

次要结局

  • 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)
  • Blood-brain barrier permeability(Baseline)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Sponsor

研究点 (1)

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