Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy
Effect of Entropy Monitoring on Sevoflurane Consumption and Recovery From General Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
The goal of this clinical trial is to learn if brainwave-guided anesthesia (entropy monitoring) can reduce anesthetic drug consumption and speed up recovery time in adult patients undergoing elective laparoscopic cholecystectomy surgery under general anesthesia.
The main questions it aims to answer are:
- Does entropy monitoring significantly decrease the mean consumption rate of sevoflurane gas (in mL/hr) compared to traditional clinical monitoring during surgery?
- Does entropy monitoring significantly reduce the mean recovery time (in minutes to open eyes on verbal command) after discontinuing anesthesia? Researchers will compare patients whose anesthesia depth is guided by real-time entropy monitoring (brainwave and facial muscle sensors) to patients whose anesthesia is guided by standard clinical signs (heart rate and blood pressure) to see if using entropy sensors reduces total anesthetic gas use and enables faster patient recovery.
Participants will:
- Receive routine pre-medication and general anesthesia induction for elective laparoscopic cholecystectomy.
- Have continuous monitoring during surgery using either entropy brain/muscle sensors (Group A) or standard clinical vital signs (Group B) to guide the delivery of sevoflurane gas.
- Have their total sevoflurane gas consumption rate automatically recorded at the end of surgery.
- Be assessed after surgery for recovery time, measured in minutes from the time sevoflurane is turned off until they open their eyes upon verbal command.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Muhammad Ali, MBBS
- 电话号码：+923334214946
- 邮箱：muhammadali_waseem@yahoo.com
学习地点
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Islamabad、巴基斯坦、44000
- 招聘中
- KRL Hospital Islamabad
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接触：
- Dr Humaira Jadoon, MBBS FCPS
- 电话号码：+92512852333
- 邮箱：drhumairajadoon@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA I or II
- Elective laparoscopic cholecystectomy under GA
Exclusion Criteria:
- Emergency cholecystectomy
- Co Morbid (Hypertension, Diabetes Mellitus, Ischemic Heart Disease, Chronic Kidney Disease, Asthma, Stroke)
- Known allergy or contraindication to sevoflurane or study drugs
- Addictions such as chronic use of sedatives, hypnotics or alcohol abuse on medical records
- BMI of 30 or greater (Obese patients tend to have delated recovery from general anesthesia)
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group A: Entropy Monitored Group
Device/Protocol: General anesthesia managed with Entropy Monitoring (GE Carestation 650). The anesthesiologist adjusts sevoflurane depth using real-time brain (EEG) and muscle (EMG) signals to maintain Response Entropy (RE) and State Entropy (SE) levels between 40 and 60, keeping the RE-SE difference under 10 |
Participants will receive general anesthesia via GE Carestation 650 Anesthesia Workstation equipped with Entropy module, maintained with sevoflurane in oxygen and air. Standard pre-medication (Midazolam 0.01-0.1 mg/kg and Nalbuphine 0.1 mg/kg), induction (Propofol in 10 mg increments), and neuromuscular blockade (Atracurium 0.5 mg/kg with NMT monitoring) will be administered. Anesthetic depth will be continuously monitored using forehead EEG/EMG sensors. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain:
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有源比较器：Group B: Clinically Monitored Group
Standard Care: General anesthesia managed using Standard Clinical Signs. The anesthesiologist adjusts sevoflurane levels based on standard clinical indicators (blood pressure, heart rate within ±20% of baseline, tearing, etc.) without using entropy numbers to guide drug dosing. |
Participants will receive identical general anesthesia premedication, induction, and airway management protocols (Midazolam, Nalbuphine, Propofol, Atracurium, and maintenance with sevoflurane in oxygen and air) as Group A. Anesthetic depth will be guided strictly using traditional clinical parameters without the aid of entropy numbers. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain: Heart rate (HR) within ±20% of the patient's baseline value. Mean Arterial Pressure (MAP) within ±20% of the patient's baseline value. Clinical signs of light anesthesia (e.g., somatic movement, excessive lacrimation, or sweating). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sevoflurane Consumption
大体时间：End of surgery (from induction of anesthesia until gas discontinuation)
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Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation |
End of surgery (from induction of anesthesia until gas discontinuation)
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Recovery Time
大体时间：From discontinuation of sevoflurane gas up to 60 minutes post-procedure
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Time required for the patient to open their eyes following a verbal command after the flow of sevoflurane gas is turned off at the end of surgery |
From discontinuation of sevoflurane gas up to 60 minutes post-procedure
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合作者和调查者
调查人员
- 学习椅：Dr Humaira Jadoon, MBBS, FCPS Anesthesia、KRL Hospital, Islamabad
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KRLHIslamabad
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
There is no plan to make IPD available
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