A prospective observational study to collect EEG recordings of hospitalized patients prior and during elective surgery under general anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Correlation of EEG recordings with the level of consciousness in patients under general anaesthesia and develop a tool
研究概览
简要总结
Defining the level of consciousness in a patient under full anaesthesia poses a challenge. Despite advancements in EEG technology and scientific knowledge, no device is available to accurately determine the depth of anaesthesia required for surgery. This results in inaccuracies when assessing the patient’s consciousness during the procedure. Metrics such as blood pressure or bispectral index fall short in characterizing consciousness levels, as they cannot entirely prevent instances of wakefulness or a certain level of consciousness during surgery. Thus, there is a need for a more precise tool to evaluate such situations. We want to develop a diagnostic tool that can consistently determine the patient’s level of consciousness, independently of subjective interpretations and across different individuals.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years (both inclusive)
- •Both male and female
- •Patients hospitalized for elective surgery under general anaesthesia
- •General anaesthesia classified as ASA 1 to 2 in the pre anaesthesia examination.
排除标准
- •Any injury or damage to the scalp or skull
- •Refusal or unwillingness to participate in the study
- •Use of medications such as beta-blockers that can affect heart rate and blood pressure.
- •Patients with a history of demyelinating disease or any progressive neurological disorder
- •Patient data with an active infection of the central nervous system, severe acute or chronic disease (haematological, renal, cancer, acquired immunodeficiency syndrome)
- •Patients with impaired consciousness from various reasons.
结局指标
主要结局
Correlation of EEG recordings with the level of consciousness in patients under general anaesthesia and develop a tool
时间窗: EEG data including 5 min of baseline activity before anaesthesia and 1-3 hours of recording during anaesthesia
次要结局
- Medications during recording/ hospitalization from the medical record in hospitalization(â— Reason for monitoring (presurgical, diagnosis))
研究者
Dr Sudheesh K
Bangalore Medical College and Research Institute