Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 3:55 PM
Study NCT ID:
NCT02893904
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol
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': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-09-04', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral profiles', 'timeFrame': 'The average value of BIS is calculated on the last minute of each ten minutes steady state period .', 'description': 'For each patient, before surgery and according to the constraints of operating schedule, one or two 10 min steady state periods were performed at a fixed FeS randomized between 1, 2, 3, 4 and 5 % of Sevoflurane in the Sevoflurane group or at a fixed Ct P randomized between 2, 3, 4, 5 and 6 mcg/ml in the propofol group.'}], 'secondaryOutcomes': [{'measure': 'Incidence of epileptiform EEG signs', 'timeFrame': 'Last minute of each ten minutes steady state period'}, {'measure': 'Spectral analysis of EEG signal', 'timeFrame': 'Last minute of each ten minutes steady state period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Propofol', 'Sevoflurane', 'Bispectral Index', 'Children', 'Electroencephalographic signs'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.\n\nThe aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.', 'detailedDescription': 'Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.\n\nSteady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.\n\nAt the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery\n\nExclusion Criteria:\n\n* obesity (body mass index \\> percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system'}, 'identificationModule': {'nctId': 'NCT02893904', 'briefTitle': 'EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.', 'orgStudyIdInfo': {'id': 'BIS and EEG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'General anesthesia by TCI Propofol and Remifentanil guided by BIS EEG monitoring intervention', 'interventionNames': ['Device: EEG monitoring', 'Device: Target Controlled Infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'General anesthesia by Sevoflurane and Remifentanil guided by BIS EEG monitoring intervention', 'interventionNames': ['Device: EEG monitoring', 'Device: Target Controlled Infusion']}], 'interventions': [{'name': 'EEG monitoring', 'type': 'DEVICE', 'description': 'Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.', 'armGroupLabels': ['Propofol', 'Sevoflurane']}, {'name': 'Target Controlled Infusion', 'type': 'DEVICE', 'otherNames': ['TCI'], 'description': 'Steady state effect site concentrations of remifentanil administrated to all patients.', 'armGroupLabels': ['Propofol', 'Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': "Departement d'anesthesie Hopital Armand Trousseau", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Armand Trousseau', 'class': 'OTHER'}, 'collaborators': [{'name': "Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr Isabelle CONSTANT', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}