Is DSA Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone in Detecting Emergence From Propofol and Opiate Anesthesia? A Prospective Observational Study in Patients Older Than 65 Years?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- aim
研究概览
简要总结
A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.
详细描述
Propofol-based total intravenous anesthesia (TIVA) is a popular general anesthesia (GA) technique with an increased risk of unintended awareness under GA, which can be a devastating and life-changing complication. Age-related changes may impact the performance of EEG-derived depth of anesthesia indices in those older than 65 years, particularly in the presence of cognitive disorders.
Hypothesis: In comparison to monitor 1 (BIS only), monitor 2 (DSA + BIS) will have higher sensitivity and specificity to detect recovery
Objectives:
Investigators will prospectively measure the sensitivity and specificity of monitor 1 versus monitor 2 in patients older than 65 years receiving propofol-based TIVA.
Methods:
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.
- •Procedures in which a DoA monitor can be applied to the forehead.
- •Patients receiving intravenous propofol and opiate anaesthesia using supraglottic airway device.
- •Patient able to provide informed consent.
- •Exclusion criteria:
- •Administration of ketamine/dexmedetomidine.
- •Administration of inhaled anaesthetic agents or nitrous oxide
- •Administration of muscle relaxation
排除标准
- 未提供
结局指标
主要结局
aim
时间窗: In the perioperative period, following the cessation of anesthesia, the patient begins to emerge from a deep anesthetic state to a lighter state and then regains consciousness. The time frame is usually in minutes, but varies depending on various factors
Sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in detection of emergence from general anesthesia. Emergence from anaesthesia manifests in changes in the BIS and/or DSA suggestive of a change in the depth of anesthesia and progress towards regaining consciousness.
Primary aim
时间窗: In the perioperative period, time following the cessation of intravenous anesthesia after the procedure; emergence from anesthesia usually takes place over a few minutes to hours.
Evaluate the sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in the detection of the timing of emergence from general anesthesia.
次要结局
未报告次要终点