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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03107832
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Murat Bilgi, Abant Izzet Baysal University

Brief 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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Procedure: thoracic epidural anesthesia procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy
Actual Study Start Date : December 30, 2012
Actual Primary Completion Date : August 25, 2013
Actual Study Completion Date : December 29, 2013

Arm Intervention/treatment
Active Comparator: 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
Procedure: thoracic epidural anesthesia procedure
general anesthesia procedure

Experimental: 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
Procedure: thoracic epidural anesthesia procedure
general anesthesia procedure




Primary Outcome Measures :
  1. patient satisfaction [ Time Frame: after postoperative 24 hour ]
    four level patient satisfaction scale


Secondary Outcome Measures :
  1. mean arterial pressure [ Time Frame: intaoperative 0, 5, 10, 15, 30, and 45 minutes ]
    physiological parameter

  2. heart rate [ Time Frame: intaoperative 0, 5, 10, 15, 30, and 45 minutes ]
    physiological parameter

  3. Blood gas analysis [ Time Frame: intaoperative 0 and 35 minutes ]
    physiological parameter

  4. Hypotension [ Time Frame: During the operation ]
    adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension

  5. Bradycardia [ Time Frame: During the operation ]
    adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia

  6. Nausea / vomiting [ Time Frame: postoperative 24 hour ]
    adverse effect

  7. Shoulder pain [ Time Frame: intraoperative and postoperative 24 hour ]
    adverse effect

  8. Sore throat [ Time Frame: postoperative 24 hour ]
    adverse effect



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107832


Locations
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Turkey
Abant Izzet Baysal University Medical School,
Bolu, Turkey, 14280
Sponsors and Collaborators
Abant Izzet Baysal University
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Responsible Party: Murat Bilgi, associate professor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03107832    
Other Study ID Numbers: AbantIBU mb2
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No