A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in the amplitude of alpha oscillations 15 minutes after incision
研究概览
简要总结
This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Electroencephalography is a test that measures brain waves and may help learn if sensitivity to anesthesia is higher in women who have received chemotherapy than women who have not. This study may help researchers learn if receiving chemotherapy before surgery can affect the way the brain responds to anesthesia during and after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To assess electroencephalography (EEG) changes of women with and without history of chemotherapy exposure undergoing volatile general anesthesia.
SECONDARY OBJECTIVE:
I. To evaluate if chemotherapy-induced cognitive impairment is associated with an increased sensitivity to general anesthetic agents captured by the patient state index (PSI) and observable in changes in alpha (8-12 H) activity in the frontal regions of the EEG) and other study features such as EEG power, burst suppression analysis, burst suppression ratio, and coherence analysis.
EXPLORATORY OBJECTIVES:
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •Women between 40-60 years of age; with or without history of systemic chemotherapy;
- •American Society of Anesthesiologists physical status (ASA) 1-3;
- •Scheduled surgery: open gynecologic surgery;
- •Able to complete all study questionnaires.
- •Exclusion criteria:
- •Emergency surgery
- •Patients with extra-abdominal metastatic disease
- •Patients unable to complete preoperative and postoperative cognitive tests
- •Non-English-speaking patients
排除标准
- 未提供
结局指标
主要结局
Difference in the amplitude of alpha oscillations 15 minutes after incision
时间窗: 15 minutes after incision
Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore differences in the analysis of the alpha oscillations
次要结局
- Coherence analysis(During surgery)
- Burst suppression analysis(During surgery)
- Patient State Index (PSI)(Up to 2 days post surgery)
- Electroencephalography (EEG) power(During surgery)
- Burst suppression ratio(During surgery)