Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00778505
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Closed-loop Anesthesia in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'difficulty in recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2008-10-22', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time during which the bispectral index is between 40 and 60', 'timeFrame': 'anesthesia'}], 'secondaryOutcomes': [{'measure': 'propofol and remifentanil doses', 'timeFrame': 'anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* class ASA I, II or III\n* general anesthesia scheduled to last more than one hour\n* intraoperative hemorrhage planned to be less than 15% of the blood volume\n\nExclusion Criteria:\n\n* Combined general and regional anesthesia,\n* Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,\n* History of a neurological or a psychiatric disorder, or central brain lesion,\n* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,\n* Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,\n* Hypersensibility to remifentanil or to a derivate of fentanyl,\n* Scheduled postoperative ventilation or sedation.'}, 'identificationModule': {'nctId': 'NCT00778505', 'acronym': 'LoopPed', 'briefTitle': 'Use of Closed-loop Anesthesia in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion', 'orgStudyIdInfo': {'id': '2008/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'closed-loop administration of propofol and remifentanil using bispectral index as the controller', 'interventionNames': ['Drug: Propofol', 'Drug: remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'manual administration of propofol and remifentanil according to bispectral index values', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'closed-loop administration using bispectral index as the controller', 'armGroupLabels': ['1']}, {'name': 'remifentanil', 'type': 'DRUG', 'description': 'closed-loop administration using bispectral index as the controller', 'armGroupLabels': ['1']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'manual administration according bispectral index values', 'armGroupLabels': ['2']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'manual administration according bispectral index values', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch, Suresnes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}