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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: thoracic epidural anesthesia procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey, 14280
    • Abant Izzet Baysal University Medical School,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	four level patient satisfaction scale	after postoperative 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	physiological parameter	intaoperative 0, 5, 10, 15, 30, and 45 minutes
heart rate	physiological parameter	intaoperative 0, 5, 10, 15, 30, and 45 minutes
Blood gas analysis	physiological parameter	intaoperative 0 and 35 minutes
Hypotension	adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension	During the operation
Bradycardia	adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia	During the operation
Nausea / vomiting	adverse effect	postoperative 24 hour
Shoulder pain	adverse effect	intraoperative and postoperative 24 hour
Sore throat	adverse effect	postoperative 24 hour

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2012
• Primary Completion (Actual): August 25, 2013
• Study Completion (Actual): December 29, 2013

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AbantIBU mb2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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