Thoracic Epidural Versus General Anaesthesia in Cholecystectomy
Condition: Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): thoracic epidural anesthesia procedure
Intervention type(s): Procedure
Intervention description(s): general anesthesia procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment