Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03107832
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2017-03-29
Brief Title:
Thoracic Epidural Versus General Anaesthesia in Cholecystectomy
Sponsor:
Abant Izzet Baysal University
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVGAC
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 2014Forty-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 groupGroup 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 groupGroup G and induction was managed using 15 mgkg fentanyl and 2 mgkg propofol 05 mgkg rocuronium and sevoflurane in a 50 oxygenair 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 USEDData 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 005
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 2012234 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None