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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)

11 april 2017 uppdaterad av: Murat Bilgi, Abant Izzet Baysal University

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kalkon
      • Bolu, Kalkon, 14280
        • Abant Izzet Baysal University Medical School,

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: general anesthesia
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
Procedur: thoracic epidural anesthesia procedure
general anesthesia procedure
Experimentell: thoracic epidural anesthesia
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
Procedur: thoracic epidural anesthesia procedure
general anesthesia procedure

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
patient satisfaction
Tidsram: after postoperative 24 hour
four level patient satisfaction scale
after postoperative 24 hour

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
mean arterial pressure
Tidsram: intaoperative 0, 5, 10, 15, 30, and 45 minutes
physiological parameter
intaoperative 0, 5, 10, 15, 30, and 45 minutes
heart rate
Tidsram: intaoperative 0, 5, 10, 15, 30, and 45 minutes
physiological parameter
intaoperative 0, 5, 10, 15, 30, and 45 minutes
Blood gas analysis
Tidsram: intaoperative 0 and 35 minutes
physiological parameter
intaoperative 0 and 35 minutes
Hypotension
Tidsram: During the operation
adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
During the operation
Bradycardia
Tidsram: During the operation
adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia
During the operation
Nausea / vomiting
Tidsram: postoperative 24 hour
adverse effect
postoperative 24 hour
Shoulder pain
Tidsram: intraoperative and postoperative 24 hour
adverse effect
intraoperative and postoperative 24 hour
Sore throat
Tidsram: postoperative 24 hour
adverse effect
postoperative 24 hour

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Abant Izzet Baysal University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 december 2012

Primärt slutförande (Faktisk)

25 augusti 2013

Avslutad studie (Faktisk)

29 december 2013

Studieregistreringsdatum

Först inskickad

29 mars 2017

Först inskickad som uppfyllde QC-kriterierna

5 april 2017

Första postat (Faktisk)

11 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • AbantIBU mb2

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Läkemedels- och apparatinformation, studiedokument

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produkt tillverkad i och exporterad från U.S.A.

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Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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