Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00181051
Status:
SUSPENDED
Last Update Posted:
2005-09-16
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 128}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of AEP guided anesthesia on recovery delay'}]}, 'conditionsModule': {'conditions': ['Scheduled General Anesthesia']}, 'descriptionModule': {'briefSummary': 'Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I-II patients\n* aged 18 - 65 years\n* scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.\n\nExclusion Criteria:\n\n* Body weight \\< 70% or \\> 150% ideal body weight\n* neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone)\n* use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.'}, 'identificationModule': {'nctId': 'NCT00181051', 'briefTitle': 'Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia', 'orgStudyIdInfo': {'id': 'PEA'}, 'secondaryIdInfos': [{'id': 'CSET 2002/948'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Alaris AEP monitor', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave-Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Michel STRUYS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de GENT - BELGIUM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}}}}