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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03107832
Acronym
EVGAC
Enrollment
40
Registered
2017-04-11
Start date
2012-12-30
Completion date
2013-12-29
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

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.

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.

Interventions

PROCEDUREthoracic epidural anesthesia procedure

general anesthesia procedure

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
patient satisfactionafter postoperative 24 hourfour level patient satisfaction scale

Secondary

MeasureTime frameDescription
heart rateintaoperative 0, 5, 10, 15, 30, and 45 minutesphysiological parameter
Blood gas analysisintaoperative 0 and 35 minutesphysiological parameter
HypotensionDuring the operationadverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
mean arterial pressureintaoperative 0, 5, 10, 15, 30, and 45 minutesphysiological parameter
Nausea / vomitingpostoperative 24 houradverse effect
Shoulder painintraoperative and postoperative 24 houradverse effect
Sore throatpostoperative 24 houradverse effect
BradycardiaDuring the operationadverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026