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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)

2017年4月11日 更新者:Murat Bilgi、Abant Izzet Baysal University

Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy

CONTEXT AND AIMS: The aim of the study is to compare patients satisfaction of thoracic epidural and general anesthesia procedures in patients undergoing elective laparoscopic cholecystectomy. SETTINGS AND DESIGN: This comparative randomized study was conducted Abant Izzet Baysal University hospital between October 2012 and 2014.Forty-five patients who were under American Society of Anesthesiologists I-II classification and were scheduled for elective laparoscopic cholecystectomy were included in the study. SUBJECTS AND METHODS: All participant was separated, two group. 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. Bispectral index -controlled sedation was provided. 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. Surgical satisfaction was recorded after pneumoperitoneum. After the operation, 75 mg diclofenac sodium was applied for patients with Numeric Rating Scale scores higher than 4. STATISTICAL ANALYSIS USED:Data analysis was performed using the Statistical Package for the Social Sciences version 18 software (SPSS, Chicago, IL, US). Descriptive variables, such as age, ASA classification, weight, height, mean arterial pressure (MAP), HR, and duration of surgery, are given as mean ± standard deviation, and an independent sample t-test (normal distribution) as well as a Mann-Whitney U test (not a normal distribution) were used for continuous variables. To compare the normal and abnormal distributions in the groups, simple t-test, and Wilcoxon test was used, respectively. The results were considered statistically significant at p-values <0.05.

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

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bolu、火鸡、14280
        • Abant Izzet Baysal University Medical School,

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
general anesthesia procedure
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
general anesthesia procedure

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

次要结果测量

结果测量
措施说明
大体时间
mean arterial pressure
大体时间:intaoperative 0, 5, 10, 15, 30, and 45 minutes
physiological parameter
intaoperative 0, 5, 10, 15, 30, and 45 minutes
heart rate
大体时间:intaoperative 0, 5, 10, 15, 30, and 45 minutes
physiological parameter
intaoperative 0, 5, 10, 15, 30, and 45 minutes
Blood gas analysis
大体时间:intaoperative 0 and 35 minutes
physiological parameter
intaoperative 0 and 35 minutes
Hypotension
大体时间:During the operation
adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
During the operation
Bradycardia
大体时间:During the operation
adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia
During the operation
Nausea / vomiting
大体时间:postoperative 24 hour
adverse effect
postoperative 24 hour
Shoulder pain
大体时间:intraoperative and postoperative 24 hour
adverse effect
intraoperative and postoperative 24 hour
Sore throat
大体时间:postoperative 24 hour
adverse effect
postoperative 24 hour

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年12月30日

初级完成 (实际的)

2013年8月25日

研究完成 (实际的)

2013年12月29日

研究注册日期

首次提交

2017年3月29日

首先提交符合 QC 标准的

2017年4月5日

首次发布 (实际的)

2017年4月11日

研究记录更新

最后更新发布 (实际的)

2017年4月12日

上次提交的符合 QC 标准的更新

2017年4月11日

最后验证

2017年4月1日

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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