Effect of Entropy Monitoring on Sevoflurane Consumption and Recovery From General Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sevoflurane Consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •Elective laparoscopic cholecystectomy under GA
排除标准
- •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
研究组 & 干预措施
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
干预措施: Entropy Monitoring-Guided Anesthesia Titration (Device)
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.
干预措施: Standard Clinical Parameter-Guided Anesthesia Titration (Other)
结局指标
主要结局
Sevoflurane Consumption
时间窗: End of surgery (from induction of anesthesia until gas discontinuation)
Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation
Recovery Time
时间窗: From discontinuation of sevoflurane gas up to 60 minutes post-procedure
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
次要结局
未报告次要终点
研究者
Muhammad Ali
PGT Anesthesia
KRL Hospital, Islamabad