A Comparison of Post-auricular and Frontal Bispectral Index Values Obtained During Renal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post-auricular and frontal BIS values
研究概览
简要总结
Electroencephalogram (EEG) derived monitors during practice of general anesthesia; allow the titration and maintenance of an adequate depth of anesthesia, advantages from reducing the recovery time after waking, as well as the risk of anesthetics adverse events .
There are various types of EEG-derived monitoring devices that are used to monitor the depth of anesthesia, and among the established devices is bispectral index (BIS) monitor. It is a quantitative electroencephalographic device that is widely used to assess the hypnotic component of anesthesia, and a level between 40 and 60 is recommended for an adequate level of the hypnotic state.
However, the use of BIS in certain surgeries is challenging because of the proximity of the forehead sensor to the surgical site. There are high possibilities of interruption of BIS recording due to contamination of the forehead sensor with blood or antiseptic cleaning solution. At the same time, the design and size of a BIS forehead sensor in the form of a long strip can also interfere with the site of surgical incision.
Several alternative BIS sensor placements have been studied for cases in which the frontal setup is not feasible. However, few studies studied the placement of the BIS sensor at the post-auricular area as an alternative method of monitoring the depth of anesthesia.
详细描述
Twelve Patients age ≥18 years, ASA I-III patients scheduled for elective renal surgeries.
Monitoring of the depth of anesthesia will be performed using an Infinity BISx SmartPod® (Aspect Medical Systems, Newton, MA, USA) and an Infinity® Delta XL monitor (Dräger Medical, Lübeck, Germany). Two standard BISx Quatro® Sensors (Aspect Medical Systems) were placed at the forehead and post-auricular area.
Before the induction of anesthesia, 2 BIS sensors (BISTM Quatro Sensors, Aspect Medical Systems, Newton, MA, USA) will be applied to each patient, 1 across the forehead and 1 along the post auricular area and attached each sensor to each BIS monitor (BIS-VistaTM monitors, Aspect Medical Systems, Newton, MA, USA).
During induction, patients will be instructed to keep their faces relaxed (eyes closed, mouth closed, no facial expressions).
The skin on the forehead will be cleaned with an alcohol 70% swab, and 2 to 5 seconds of digital pressure applied over the sensor leads. The sensor is comprised of disposable wet gel electrodes. Electromyographic activity of the frontalis muscle is measured by lead 4, which is the ground electrode as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients aged≥18 years
- •ASA I-III
- •patients scheduled for elective renal surgeries
排除标准
- •Patients with disabling central nervous system
- •cerebrovascular disease
- •those currently taking psychiatric medication
- •those with a history of neurosurgical intervention
- •those with contraindications for the placement of electrodes over forehead and post-auricular area (e.g., having skin infections)
结局指标
主要结局
Post-auricular and frontal BIS values
时间窗: 5 minutes before induction of aneasthesia
Post-auricular and frontal BIS values
次要结局
未报告次要终点
研究者
Amany Faheem
Assistant professor of anesthesiology, intensive care, and pain medicine
Tanta University