Analyzing bispectral index electrode placement: Comparisons between frontal and mandibular v/s frontal and postauricular locations, followed by intergroup analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The primary aim of this study is to evaluate the validity of alternative placements of the Bispectral Index
研究概览
简要总结
Introduction The Bispectral Index is a widely used tool for monitoring the depth of anesthesia, derived
from electroencephalography (EEG) signal analysis. Accurate BIS readings are crucial for optimal
anesthetic management. Traditional frontal electrode placement is sometimes impractical, necessitating
exploration of alternative placements.
Objective To compare the accuracy and reliability of BIS readings from frontal, mandibular, and frontal
post-auricular electrode placements and conduct inter-group analysis to determine the most effective
alternative to the frontal placement.
Methods
Study Design: A prospective, comparative observational study.
Participants: 130 patients undergoing neurosurgeries with neuro anesthesia, randomized into two
groups (65 per group) based on electrode placement: frontal, mandibular, and frontal , post-
auricular.
Data Collection: BIS readings, signal quality index (SQI), and electromyography (EMG) scores
were recorded at six stages: pre-anesthesia, induction, muscle relaxation maintenance, closure,
and extubation.
Analysis: Statistical methods will be used to compare BIS values, SQI, and EMG scores across
different placements and between groups. Correlation coefficients will be assessed with the
agreement between frontal and alternative placements.
Keywords: Bispectral Index, BIS, electrode placement, anesthesia monitoring, EEG, frontal, mandibular,
post-auricular, patient safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 and above and below 65 yrs
- •ASA physical status I or II
- •Scheduled for various neurosurgical , cranial and spinal procedures.
排除标准
- •Presence of skin lesions or scars at potential sensor sites that could impede sensor placement or function.
- •Allergies: Known hypersensitivity to adhesives or materials used in BIS sensors.
- •Bearded individuals for mandibular placement of electrodes
- •GCS less than 15.
结局指标
主要结局
The primary aim of this study is to evaluate the validity of alternative placements of the Bispectral Index
时间窗: The time points would be the following | 1. Baseline | 2. 90 seconds after administration of fentanyl and propofol | 3. 3 mins after giving muscle relaxant | 4. At intubation | 5. At the time of first pain stimulus | 6. Every 30 s into the procedure | 7. At extubation
sensor—specifically the mandibular and post auricular positions—compared to the traditional frontal
时间窗: The time points would be the following | 1. Baseline | 2. 90 seconds after administration of fentanyl and propofol | 3. 3 mins after giving muscle relaxant | 4. At intubation | 5. At the time of first pain stimulus | 6. Every 30 s into the procedure | 7. At extubation
placement, in measuring the depth of anesthesia during surgical procedures.
时间窗: The time points would be the following | 1. Baseline | 2. 90 seconds after administration of fentanyl and propofol | 3. 3 mins after giving muscle relaxant | 4. At intubation | 5. At the time of first pain stimulus | 6. Every 30 s into the procedure | 7. At extubation
次要结局
- Practicality of Sensor
研究者
Shivani Fotedar
Artemis Health Institute