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Completed

NCT Number: NCT03107832

Thoracic Epidural Versus General Anaesthesia in 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.

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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal University Medical School,

Bolu, 14280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

thoracic epidural anesthesia procedure

Procedure

general anesthesia procedure

Primary outcomes

  1. patient satisfaction

    Time frame: after postoperative 24 hour

    four level patient satisfaction scale

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Acronym: EVGAC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2017
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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