Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)
Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy
研究概览
详细说明
This comparative randomized study included 45 patients in this study following receiving institutional ethical committee approval (Clinical Ethical Committee of Abant Izzet Baysal University, Bolu, Turkey. Ethical Committee Number: 2012/234) and collecting informed consent. Pre-anesthetic evaluations were conducted in these patients who were between the ages of 18 and 75 and fell into American Society of Anesthesiologists (ASA) risk categories I-II who were scheduled for elective laparoscopic cholecystectomy. Exclusion criteria; patients with any of the following: allergies against any of the drugs to be used in the study, current pregnancy, severe cardiac, renal, and liver diseases, previous upper abdominal surgery, acute cholangitis, a body mass index >32 kg m2, contraindications for epidural anesthesia and elective surgery.
All the patients received preoperative evaluations, were informed about the study, provided their informed consent, and were informed about the method of anesthesia to be applied In this study, present a comparison of patients and surgical satisfaction and hemodynamic changes of patients for whom an elective laparoscopic cholecystectomy procedure was planned.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bolu、火鸡、14280
- Abant Izzet Baysal University Medical School,
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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:
- American Society of Anesthesiologists I-II classification ,
- Elective laparoscopic cholecystectomy ,
- Ages of 18 and 75
Exclusion Criteria:
- allergies against any of the drugs to be used in the study,
- current pregnancy,
- severe cardiac, renal, and liver diseases,
- previous upper abdominal surgery,
- acute cholangitis,
- a body mass index >32 kg m2,
- contraindications for epidural anesthesia and elective surgery
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:general anesthesia
In general anesthesia group (Group G), and induction was managed using 1.5 mg/kg fentanyl and 2 mg/kg propofol; 0.5 mg/kg rocuronium and sevoflurane in a 50% oxygen /air mixture was used.
Blood gas analysis monitoring was performed in the 30th minute before and after pneumoperitoneum
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general anesthesia procedure
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实验性的:thoracic epidural anesthesia
In epidural anesthesia group(Group E), a catheter was installed and received 20 mg lidocaine hydrochloride, 15 mg bupivacaine, and 25 mg fentanyl citrate adjusted to 10 cc with normal saline to be injected by the epidural catheter.
Bi-spectral index -controlled sedation was provided
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general anesthesia procedure
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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 |
|---|---|---|
|
patient satisfaction
大体时间:after postoperative 24 hour
|
four level patient satisfaction scale
|
after postoperative 24 hour
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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mean arterial pressure
大体时间:intaoperative 0, 5, 10, 15, 30, and 45 minutes
|
physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
|
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heart rate
大体时间:intaoperative 0, 5, 10, 15, 30, and 45 minutes
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physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
|
|
Blood gas analysis
大体时间:intaoperative 0 and 35 minutes
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physiological parameter
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intaoperative 0 and 35 minutes
|
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Hypotension
大体时间:During the operation
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adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
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During the operation
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Bradycardia
大体时间:During the operation
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adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia
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During the operation
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Nausea / vomiting
大体时间:postoperative 24 hour
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adverse effect
|
postoperative 24 hour
|
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Shoulder pain
大体时间:intraoperative and postoperative 24 hour
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adverse effect
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intraoperative and postoperative 24 hour
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Sore throat
大体时间:postoperative 24 hour
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adverse effect
|
postoperative 24 hour
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
- AbantIBU mb2
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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