Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT03107832
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Epidural Versus General Anaesthesia in Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'after postoperative 24 hour', 'description': 'four level patient satisfaction scale'}], 'secondaryOutcomes': [{'measure': 'mean arterial pressure', 'timeFrame': 'intaoperative 0, 5, 10, 15, 30, and 45 minutes', 'description': 'physiological parameter'}, {'measure': 'heart rate', 'timeFrame': 'intaoperative 0, 5, 10, 15, 30, and 45 minutes', 'description': 'physiological parameter'}, {'measure': 'Blood gas analysis', 'timeFrame': 'intaoperative 0 and 35 minutes', 'description': 'physiological parameter'}, {'measure': 'Hypotension', 'timeFrame': 'During the operation', 'description': 'adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension'}, {'measure': 'Bradycardia', 'timeFrame': 'During the operation', 'description': 'adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia'}, {'measure': 'Nausea / vomiting', 'timeFrame': 'postoperative 24 hour', 'description': 'adverse effect'}, {'measure': 'Shoulder pain', 'timeFrame': 'intraoperative and postoperative 24 hour', 'description': 'adverse effect'}, {'measure': 'Sore throat', 'timeFrame': 'postoperative 24 hour', 'description': 'adverse effect'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * American Society of Anesthesiologists I-II classification ,\n * Elective laparoscopic cholecystectomy ,\n * Ages of 18 and 75\n* Exclusion Criteria:\n\n * allergies against any of the drugs to be used in the study,\n * current pregnancy,\n * severe cardiac, renal, and liver diseases,\n * previous upper abdominal surgery,\n * acute cholangitis,\n * a body mass index \\>32 kg m2,\n * contraindications for epidural anesthesia and elective surgery'}, 'identificationModule': {'nctId': 'NCT03107832', 'acronym': 'EVGAC', 'briefTitle': 'Thoracic Epidural Versus General Anaesthesia in Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'AbantIBU mb2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia', 'description': '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', 'interventionNames': ['Procedure: thoracic epidural anesthesia procedure']}, {'type': 'EXPERIMENTAL', 'label': 'thoracic epidural anesthesia', 'description': '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', 'interventionNames': ['Procedure: thoracic epidural anesthesia procedure']}], 'interventions': [{'name': 'thoracic epidural anesthesia procedure', 'type': 'PROCEDURE', 'description': 'general anesthesia procedure', 'armGroupLabels': ['general anesthesia', 'thoracic epidural anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14280', 'city': 'Bolu', 'state': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University Medical School,', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Murat Bilgi', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}