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临床试验/NCT03107832
NCT03107832已完成不适用

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

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
patient satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists I-II classification ,
  • Elective laparoscopic cholecystectomy ,
  • Ages of 18 and 75

排除标准

  • 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

结局指标

主要结局

patient satisfaction

时间窗: after postoperative 24 hour

four level patient satisfaction scale

次要结局

  • heart rate(intaoperative 0, 5, 10, 15, 30, and 45 minutes)
  • Blood gas analysis(intaoperative 0 and 35 minutes)
  • Nausea / vomiting(postoperative 24 hour)
  • Shoulder pain(intraoperative and postoperative 24 hour)
  • mean arterial pressure(intaoperative 0, 5, 10, 15, 30, and 45 minutes)
  • Bradycardia(During the operation)
  • Sore throat(postoperative 24 hour)
  • Hypotension(During the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Bilgi

associate professor

Abant Izzet Baysal University

研究点 (2)

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