The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- BIS50
研究概览
简要总结
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.
详细描述
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A potential subject may be included for participation in the study if the subject has/is:
- •≥18 years of age
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Able and willing to participate in the study and sign the informed consent form
- •Will undergo non-ambulatory elective surgery under general anesthesia
- •Has an expected surgery time >2 hours
排除标准
- •A potential subject will be excluded from participating in the study if the subject has/is:
- •Unwilling to undergo EEG measurement
- •Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
- •Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.
- •Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)
- •Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
- •Severe visual or auditory disorder
- •Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment
结局指标
主要结局
BIS50
时间窗: 8 hours
The Bispectral Index (BIS) value, a scale 0-100 with 0 being no brain activity and 100 being fully conscious, at which 50% of subjects are anesthetized at a level they are considered uncounscious based on the MOAA/S score of 0-2
次要结局
未报告次要终点