Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03424720
Status:
UNKNOWN
Last Update Posted:
2018-02-07
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PLE value during induction and emergence of general anesthesia', 'timeFrame': 'Through study completion, an average of fifteen months', 'description': 'Investigators measure the PLE value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia.\n\nThe PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).'}], 'secondaryOutcomes': [{'measure': 'BIS value during induction and emergence of general anesthesia', 'timeFrame': 'Through study completion, an average of fifteen months', 'description': 'Investigators measure the BIS value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia.\n\nThe BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).'}, {'measure': 'PLE value during facial nerve integrity monitoring', 'timeFrame': 'Through study completion, an average of fifteen months', 'description': 'Investigators measure the PLE value at the time points of facial nerve integrity monitoring.\n\nThe PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).'}, {'measure': 'BIS value during facial nerve integrity monitoring', 'timeFrame': 'Through study completion, an average of fifteen months', 'description': 'Investigators measure the BIS value at the time points of facial nerve integrity monitoring.\n\nThe BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator', 'detailedDescription': '1. To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.\n2. In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2\n\nExclusion Criteria:\n\n* Patient who has been taken anticonvulsant agents, sedatives, and hypnotics\n* Patient who has central nerve system disease, neurological disorder\n* Patient with hypersensitivity to anesthetics'}, 'identificationModule': {'nctId': 'NCT03424720', 'briefTitle': 'Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring', 'orgStudyIdInfo': {'id': '3-2017-10047988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparison of PLE and BIS', 'description': 'Investigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring', 'interventionNames': ['Device: PLE and BIS']}], 'interventions': [{'name': 'PLE and BIS', 'type': 'DEVICE', 'description': 'Investigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics', 'armGroupLabels': ['Comparison of PLE and BIS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung Mi Kim, Ph.D.', 'role': 'CONTACT', 'phone': '82313803945'}, {'name': 'Kyung Mi Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}], 'centralContacts': [{'name': 'Kyung Mi Kim, Ph.D.', 'role': 'CONTACT', 'email': 'sumsonyo@hallym.or.kr', 'phone': '82313803945'}], 'overallOfficials': [{'name': 'Kyung Mi Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff, Department of Anesthesiology and pain Medicine, Principal Investigator, Assistant Professor.', 'investigatorFullName': 'Kyung Mi Kim', 'investigatorAffiliation': 'Hallym University Medical Center'}}}}