Thoracic Epidural Versus General Anaesthesia in Cholecystectomy

NCT03107832 | Completed

• 1 other identifier: AbantIBU mb2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  four level patient satisfaction scale

  after postoperative 24 hour

Secondary Outcomes (8)

• mean arterial pressure

  intaoperative 0, 5, 10, 15, 30, and 45 minutes

• heart rate

  intaoperative 0, 5, 10, 15, 30, and 45 minutes

• Blood gas analysis

  intaoperative 0 and 35 minutes

• Hypotension

  During the operation

• Bradycardia

  During the operation

Study Arms (2)

general anesthesia

ACTIVE COMPARATOR

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

thoracic epidural anesthesia

EXPERIMENTAL

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

Interventions

thoracic epidural anesthesia procedure PROCEDURE

general anesthesia procedure

general anesthesia; thoracic epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists I-II classification ,
• Elective laparoscopic cholecystectomy ,
• Ages of 18 and 75

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University Medical School,

Bolu, Bolu, 14280, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 11, 2017
• Study Start: December 30, 2012
• Primary Completion: August 25, 2013
• Study Completion: December 29, 2013
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)