Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-22 @ 12:29 PM
Study NCT ID:
NCT02792751
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2016-05-27', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of BIS on oxidative stress', 'timeFrame': 'one day', 'description': 'The investigators aimed to investigate the effects of anesthesia with monitoring the depth of anesthesia using BIS on oxidative stres by measuring the total oxidant status (TAS) and total antioxidant status (TOS) , propofol consumption, and postoperative recovery during ERCP procedures in this study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depth of anesthesia', 'BIS', 'ERCP', 'Positive Regulation'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.', 'detailedDescription': '50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with American Society of Anesthesiologists physical status I-II\n* Patients undergoing ERCP procedures\n\nExclusion Criteria:\n\n* uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)\n* difficulty in communication (language problems, such as deafness)\n* who are allergic to the drugs used\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02792751', 'briefTitle': 'Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Effects of Bispectral Index on Oxidative Stress', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group R (Ramsey)=25 patients', 'description': 'Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R', 'interventionNames': ['Other: Ramsey Sedation Scale']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (BIS)=25 patients', 'description': 'Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B.', 'interventionNames': ['Device: Bispectral Index Monitorisation (BIS)']}], 'interventions': [{'name': 'Bispectral Index Monitorisation (BIS)', 'type': 'DEVICE', 'description': 'Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients', 'armGroupLabels': ['Group B (BIS)=25 patients']}, {'name': 'Ramsey Sedation Scale', 'type': 'OTHER', 'description': 'Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4', 'armGroupLabels': ['Group R (Ramsey)=25 patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}