Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)
11 april 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bolu, Kalkoen, 14280
- Abant Izzet Baysal University Medical School,
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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
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general anesthesia procedure
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Experimenteel: 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
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general anesthesia procedure
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
patient satisfaction
Tijdsspanne: after postoperative 24 hour
|
four level patient satisfaction scale
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after postoperative 24 hour
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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mean arterial pressure
Tijdsspanne: intaoperative 0, 5, 10, 15, 30, and 45 minutes
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physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
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heart rate
Tijdsspanne: intaoperative 0, 5, 10, 15, 30, and 45 minutes
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physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
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Blood gas analysis
Tijdsspanne: intaoperative 0 and 35 minutes
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physiological parameter
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intaoperative 0 and 35 minutes
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Hypotension
Tijdsspanne: During the operation
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adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
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During the operation
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Bradycardia
Tijdsspanne: During the operation
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adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia
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During the operation
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Nausea / vomiting
Tijdsspanne: postoperative 24 hour
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adverse effect
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postoperative 24 hour
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Shoulder pain
Tijdsspanne: intraoperative and postoperative 24 hour
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adverse effect
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intraoperative and postoperative 24 hour
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Sore throat
Tijdsspanne: postoperative 24 hour
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adverse effect
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postoperative 24 hour
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
30 december 2012
Primaire voltooiing (Werkelijk)
25 augustus 2013
Studie voltooiing (Werkelijk)
29 december 2013
Studieregistratiedata
Eerst ingediend
29 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
5 april 2017
Eerst geplaatst (Werkelijk)
11 april 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 april 2017
Laatste update ingediend die voldeed aan QC-criteria
11 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- AbantIBU mb2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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