Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-05 @ 5:42 PM
Study NCT ID:
NCT03069456
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Combined sigmoidal Emax models from anesthetic depth monitoring for sedation (ADMS) and combined sigmoidal Emax models from bispectral index (BIS) via population pharmacodynamic approach.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral Index (BIS)', 'timeFrame': 'Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes', 'description': 'captured BIS data (0\\~100) from the BIS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min.'}, {'measure': 'Anesthetic depth monitoring for sedation (ADMS)', 'timeFrame': 'Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes', 'description': 'captured ADMS data (0\\~100) from the ADMS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'visit patients 24 hours after operation.', 'description': 'Observe all adverse events both groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sevoflurane', 'Bistpectral index', 'Anesthetic Depth Monitoring System', 'population pharmacodynamics'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '21892201', 'type': 'BACKGROUND', 'citation': 'Han DW, Linares-Perdomo OJ, Lee JS, Kim JH, Kern SE. Comparison between cerebral state index and bispectral index as measures of electroencephalographic effects of sevoflurane using combined sigmoidal E(max) model. Acta Pharmacol Sin. 2011 Oct;32(10):1208-14. doi: 10.1038/aps.2011.99. Epub 2011 Sep 5.'}, {'pmid': '19711188', 'type': 'BACKGROUND', 'citation': 'Kreuer S, Bruhn J, Wilhelm W, Grundmann U, Rensing H, Ziegeler S. Comparative pharmacodynamic modeling of desflurane, sevoflurane and isoflurane. J Clin Monit Comput. 2009 Oct;23(5):299-305. doi: 10.1007/s10877-009-9196-6. Epub 2009 Aug 27.'}, {'pmid': '10443602', 'type': 'BACKGROUND', 'citation': 'Rehberg B, Bouillon T, Zinserling J, Hoeft A. Comparative pharmacodynamic modeling of the electroencephalography-slowing effect of isoflurane, sevoflurane, and desflurane. Anesthesiology. 1999 Aug;91(2):397-405. doi: 10.1097/00000542-199908000-00013.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to compare the performance of anesthetic depth monitoring for sedation (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.', 'detailedDescription': 'Intraoperative awareness under general anesthesia is rare, but it may cause serious psychological sequelae. Anesthetic depth monitoring system based on electroencephalography(EEG) or evoked potential are broadly used methods. Bispectral index (BIS) monitor is most popular anesthetic depth monitoring system. Anesthetic depth monitoring for sedation (ADMS) is developed in Korea as an electroencephalographic monitor for measuring the depth of anesthesia. The investigators want to compare the performance of ADMS to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients scheduled for an elective operation and postoperative epidural PCA with ASA physical status 1,2,3 who have signed the wrtten informed consent.\n\nExclusion Criteria:\n\n* preventive anticoagulation treatment\n* Significant liver, kidney, coagulation dysfunction\n* Clinically significant ECG abnormalities\n* administration of psychologic durgs or opioid within 14 days before surgery'}, 'identificationModule': {'nctId': 'NCT03069456', 'briefTitle': 'Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral Index', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using Anesthetic Depth Monitoring for Sedation (ADMS) and Bispectral Index System (BIS)', 'orgStudyIdInfo': {'id': 'CNUHH-2015-067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BIS group', 'description': 'Combined sigmoidal Emax models from the BIS data', 'interventionNames': ['Device: BIS']}, {'type': 'EXPERIMENTAL', 'label': 'ADMS group', 'description': 'Combined sigmoidal Emax models from the ADMS data', 'interventionNames': ['Device: ADMS']}], 'interventions': [{'name': 'BIS', 'type': 'DEVICE', 'armGroupLabels': ['BIS group']}, {'name': 'ADMS', 'type': 'DEVICE', 'armGroupLabels': ['ADMS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-763', 'city': 'Hwasun', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chanhong Park', 'role': 'CONTACT', 'email': 'cnuhpch@naver.com', 'phone': '+82-61-379-7598'}], 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}], 'centralContacts': [{'name': 'Tae-hee Pyeon, MD', 'role': 'CONTACT', 'email': 'skybluevus@naver.com', 'phone': '+82-10-2705-9901'}], 'overallOfficials': [{'name': 'SEONGWOOK JEONG, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Seongwook Jeong', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}