Clinical trial NCT03107832: Thoracic Epidural Versus General Anaesthesia in Cholecystectomy
Official title: Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: patient satisfaction
timeFrame: after postoperative 24 hour
Secondary outcomes:
measure: mean arterial pressure
timeFrame: intaoperative 0, 5, 10, 15, 30, and 45 minutes
measure: heart rate
timeFrame: intaoperative 0, 5, 10, 15, 30, and 45 minutes
measure: Blood gas analysis
timeFrame: intaoperative 0 and 35 minutes
measure: Hypotension
timeFrame: During the operation
measure: Bradycardia
timeFrame: During the operation
measure: Nausea / vomiting
timeFrame: postoperative 24 hour
measure: Shoulder pain
timeFrame: intraoperative and postoperative 24 hour
measure: Sore throat
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Medical School,
Study officials:
References: