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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)

11. april 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / 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
Procedure: thoracic epidural anesthesia procedure
general anesthesia procedure
Eksperimentel: 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
Procedure: thoracic epidural anesthesia procedure
general anesthesia procedure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
patient satisfaction
Tidsramme: after postoperative 24 hour
four level patient satisfaction scale
after postoperative 24 hour

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abant Izzet Baysal University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. december 2012

Primær færdiggørelse (Faktiske)

25. august 2013

Studieafslutning (Faktiske)

29. december 2013

Datoer for studieregistrering

Først indsendt

29. marts 2017

Først indsendt, der opfyldte QC-kriterier

5. april 2017

Først opslået (Faktiske)

11. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AbantIBU mb2

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kirurgisk procedure, uspecificeret

Kliniske forsøg med thoracic epidural anesthesia procedure

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