Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00392158
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2006-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable
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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2006-10-24', 'studyFirstSubmitQcDate': '2006-10-24', 'lastUpdatePostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)'}], 'secondaryOutcomes': [{'measure': 'consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia'}, {'measure': 'number of modifications of target of propofol and remifentanil'}, {'measure': 'number of episodes of hemodynamic anomalies having required a treatment'}, {'measure': 'intraoperative volume loading and transfusion'}, {'measure': 'extubation time, explicit memorisation'}, {'measure': 'dysfunctions of each system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia, General']}, '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.'}, {'pmid': '16672092', 'type': 'BACKGROUND', 'citation': 'Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.'}]}, 'descriptionModule': {'briefSummary': 'To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia', '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, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as the control actuator. Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system 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. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. 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 anesthesia system group to do similar or better.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery under general anesthesia using relaxant agent,\n* surgery lasting more than one hour\n\nExclusion Criteria:\n\n* pregnant women,\n* indication for rapid sequence induction,\n* anticipation of difficult intubation,\n* allergy to propofol or remifentanil,\n* neurological or muscular disorder,\n* combination of general anesthesia and of regional anesthesia,\n* emergency surgery.'}, 'identificationModule': {'nctId': 'NCT00392158', 'briefTitle': 'Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion', 'orgStudyIdInfo': {'id': 'Foch-3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Closed-loop anesthesia system', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': "Dept of Anesthesia, CH d'Argenteuil", 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Dept of Anesthesiology, CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33074', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Dept of Anesthesia, Clinique Saint Augustin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Dept of Anesthesia and Intensive Care, Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Dept of Anesthesiology, Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Dept of Anesthesia, Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}}}}