Thoracic Epidural Versus General Anaesthesia in Cholecystectomy

Surgical Procedure, Unspecified Clinical Trial

— EVGAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107832
• Other study ID #: AbantIBU mb2
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 11, 2017
• Start date: December 30, 2012
• Est. completion date: December 29, 2013

Study information

• Verified date: April 2017
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 29, 2013
• Est. primary completion date: August 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Procedure:
• thoracic epidural anesthesia procedure
general anesthesia procedure

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University Medical School,	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

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