Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-09 @ 9:23 AM
Study NCT ID:
NCT02742012
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Multimodal Indicator of Depth of Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness', 'timeFrame': '1 minute'}], 'secondaryOutcomes': [{'measure': "the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia", 'timeFrame': '1 minute'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['electroencephalogram', 'hemodynamic monitoring', 'respiratory monitoring'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).\n\nThe indicator previously developed shall now be tested on an independent set of data.\n\nThe investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.\n\nThe design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '250 adult patients scheduled for elective surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* elective surgery under general anesthesia\n* anticipated operating time of about one hour or longer\n* ASA physical status I-III\n* written informed consent\n\nExclusion Criteria:\n\n* chronic intake of CNS affecting drugs\n* alcohol or drug abuse in the last three months\n* CNS or psychiatric disease\n* hardness of hearing or deafness\n* abnormal gastrointestinal motility\n* non-adherence to fasting guidelines, emergency surgery\n* anticipated difficult airway\n* pregnancy\n* cardiac surgery and surgery involving the head and/or neck\n* postoperatively prolonged intubation\n* pre- and/or postoperative intensive care treatment'}, 'identificationModule': {'nctId': 'NCT02742012', 'briefTitle': 'Validation of a Multimodal Indicator of Depth of Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters', 'orgStudyIdInfo': {'id': 'AMI-1250-KIE-0250-I'}}, 'armsInterventionsModule': {'interventions': [{'name': 'the study is observational', 'type': 'OTHER', 'description': 'the study is observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Department of Anesthesiology', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '42283', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Klinik für Anästhesiologie am Helios Klinikum', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Eberhard F Kochs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum rechts der Isar Technische Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Andreas Ranft', 'investigatorAffiliation': 'Technical University of Munich'}}}}