跳至主要内容
临床试验/NCT06490588
NCT06490588尚未招募不适用

The Use of Sevoflurane to Test the Concept of Intra-individual Variability in Bispectral Index Monitor and Cognitive Reserve by Examining Time to Emergence and Recovery

Los Angeles General Medical Center0 个研究点目标入组 70 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
intraoperative BIS variability

研究概览

简要总结

Previous pilot study had demonstrated a correlation between cognitive reserve and BIS variability during steady state of anesthesia. This study, we intend to evaluate the association between BIS variability and emergence and recovery time from anesthesia.

详细描述

Cognitive reserve (CR) refers to an individual's ability to resist damage to the brain and is thought to be associated with an individual's education, cognitive stimulation, and physical activity. Those with greater CR have protection against degenerative brain changes such as dementia. Currently, CR is evaluated through a host of proxy tests such as questionnaires aimed to assess various aspects of cognitive function. These ways of measuring CR test directly only on an individual's ability to perform certain tasks when the brain is in its "unchallenged" state. However, this approach poses significant limitations since CR is developed as a concept representing the physiological brain reserve that helps counter the clinical manifestation of a diseased or "challenged" brain. A method that simulates a state of "challenged" brain during CR measurement may provide a more precise assessment of CR.

Anesthetic agents are known to reversibly alter brain function resulting in a state of sedation or amnesia. Whether this way of brain "challenge" can provide information on CR is unknown.

A previous study showed preliminary evidence that patients with higher CR correlates with less variability in bispectral index (BIS) during steady state of anesthesia with inhaled anesthetic sevoflurane (1). While the result of this study is encouraging, further study is needed to develop the concept of using anesthetic agents to evaluate CR. Specifically, a study investigating the correlation between intraoperative BIS variability and timing of clinical recovery from anesthesia will be necessary. This will further elucidate how to use anesthetic agent for the evaluation of CR.

Building on the previous study result and the concept that higher CR means higher resilience against brain function in a "challenged" state, we hypothesize that less intraoperative BIS variability correlates with shorter recovery time from anesthesia.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Minimal completion of high-school education
  • Adult patient < 85 years of age
  • No prior known history of cognitive/brain disease
  • ASA class I-II
  • Undergoing general anesthesia with sevoflurane for maintenance anesthesia
  • Same-day surgery
  • Elective procedures
  • No prior history of cardiac disease

排除标准

  • - History of chronic pain
  • Perioperative use of anesthetic agents other than propofol, fentanyl, dilaudid, and sevoflurane
  • History of alcohol/substance druge abuse
  • Psychiatric history
  • Morbid history
  • History of OSA, stroke, or TIA
  • Blindness

结局指标

主要结局

intraoperative BIS variability

时间窗: 360 minutes

次要结局

  • time to recovery(120 minutes)

研究者

发起方
Los Angeles General Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jody Chou

Physician Specialist

Los Angeles General Medical Center

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