Effect of patient positions on the Bispectral Index and Entropy Index in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bispectral Index and Entropy Index values in different patient positions
研究概览
简要总结
This is an observational study to assess the impact of different patient positions on Bispectral Index and Entropy Index in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia which will be conducted at ABVIMS and Dr. RML Hospital, New Delhi - 110001. The sample size for the study is 100.
The primary objective is to study the change in the values of Bispectral Index and Entropy Index in different patient positions in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia.
The study has two secondary objectives. The first is to study the changes in hemodynamic parameters( Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Mean Arterial Pressure) with change in position in the study population.The second is to measure the time taken for values of Bispectral Index and Entropy Index to return to target value.
In each subject, baseline values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded in neutral supine position. The subject’s position will the be changed to head up(30 degrees) with left lateral tilt(15 degrees) and the values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded at baseline, 15 secs, 30 secs, 1min, 2mins, 5 mins and 10 mins. The time taken for the values of Bispectral Index and Entropy Index to return to target value will also be noted. The subject’s position will the be changed to neutral supine and the values of Bispectral Index, Entropy Index and hemodynamic parameters will be recorded at baseline, 15 secs, 30 secs, 1min, 2mins, 5 mins and 10 mins. The time taken for the values of Bispectral Index and Entropy Index to return to target value will also be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists physical status I and II patients posted for elective Laparoscopic Cholecystectomy under General Anaesthesia.
排除标准
- •Patients with history of previous neurosurgery
- •Patients with known neurological or cognitive disorders
- •Patients taking psychiatric medications
- •Patients taking drugs that act on the central nervous system.
结局指标
主要结局
Bispectral Index and Entropy Index values in different patient positions
时间窗: 1. Baseline | 2. 15 secs | 3. 30 secs | 4. 1 min | 5. 2 mins | 6. 5 mins | 7. 10 mins
(1. Supine/Neutral
时间窗: 1. Baseline | 2. 15 secs | 3. 30 secs | 4. 1 min | 5. 2 mins | 6. 5 mins | 7. 10 mins
2. Head up(30 degrees with left lateral tilt(15 degrees)
时间窗: 1. Baseline | 2. 15 secs | 3. 30 secs | 4. 1 min | 5. 2 mins | 6. 5 mins | 7. 10 mins
3. Supine/Neutral)
时间窗: 1. Baseline | 2. 15 secs | 3. 30 secs | 4. 1 min | 5. 2 mins | 6. 5 mins | 7. 10 mins
次要结局
- Hemodynamic Parameters( Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate)in different patient positions(1. Baseline)
- Time taken for values of Bispectral Index and Entropy Index to return to Target Value
研究者
Ria Treasa James
ABVIMS and Dr. RML Hospital