Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-26 @ 9:18 PM
Study NCT ID:
NCT00393003
Status:
COMPLETED
Last Update Posted:
2009-08-31
First Post:
2006-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-28', 'studyFirstSubmitDate': '2006-10-24', 'studyFirstSubmitQcDate': '2006-10-25', 'lastUpdatePostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global score (calculated parameter which depicts the performance of the system)'}], 'secondaryOutcomes': [{'measure': 'Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Sedation'], 'conditions': ['Postoperative Sedation']}, 'referencesModule': {'references': [{'pmid': '16571963', 'type': 'BACKGROUND', 'citation': 'Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.', 'detailedDescription': 'The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop system group to do similar or better.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status 1-3\n* Abdominal aorta surgery\n\nExclusion Criteria:\n\n* Pregnant women\n* Neurological or muscular disorder'}, 'identificationModule': {'nctId': 'NCT00393003', 'briefTitle': 'Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion', 'orgStudyIdInfo': {'id': 'Foch-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Closed-loop anesthesia system', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière', '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': 'Morgan Le Guen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière, 75013 Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marc Fischler', 'oldOrganization': 'Hopital Foch'}}}}