Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-22 @ 6:46 PM
Study NCT ID:
NCT04105660
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of recovery (QoR): QoR-15 scale', 'timeFrame': '24 hours after surgery', 'description': 'QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)'}], 'secondaryOutcomes': [{'measure': 'Propofol consumption', 'timeFrame': 'during anaesthesia', 'description': 'Propofol consumption in mg/kg/h'}, {'measure': 'Quality of recovery (QoR): QoR-15 scale', 'timeFrame': '48 hours after surgery', 'description': 'QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)'}, {'measure': 'Time spent in postanaesthesia care unit (PACU)', 'timeFrame': 'At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes)', 'description': 'Time in minutes from arrival in PACU until discharge from PACU'}, {'measure': 'Time to extubation', 'timeFrame': 'At time of skin closure and at time of extubation (an average of 90 minutes)', 'description': 'Time in minutes from skin closure to extubation'}, {'measure': 'Risk of awareness', 'timeFrame': 'daily from admission up to hospital discharge, an average of approximately 14 days', 'description': 'Brice interview daily until hospital discharge'}, {'measure': 'Aldrete score', 'timeFrame': 'Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital', 'description': 'Measurement of recovery; score is 0 to 10, 0 means worst recovery, 10 means best recovery'}, {'measure': 'Incidence of Postoperative Nausea and Vomiting (PONV)', 'timeFrame': 'daily from admission up to hospital discharge, an average of approximately 14 days', 'description': 'Incidence of nausea and vomiting daily until hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '35688587', 'type': 'DERIVED', 'citation': "Gruber BU, Girsberger V, Kusstatscher L, Funk S, Luethy A, Jakus L, Maillard J, Steiner LA, Dell-Kuster S, Burkhart CS. Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the 'EEG in General Anaesthesia - More Than Only a Bispectral Index' Trial, a multicentre, double-blind, randomised controlled trial. BMJ Open. 2022 Jun 10;12(6):e059919. doi: 10.1136/bmjopen-2021-059919."}]}, 'descriptionModule': {'briefSummary': 'Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.', 'detailedDescription': "Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia. In addition to the bispectral (BIS) index displayed as an index, the raw frontal EEG can be displayed as a curve on these monitors. After a short training, anaesthetists might be more accurate and faster in assessing depth of anaesthesia by recognizing the pattern of the EEG curve than by using the BIS index. This may further enhance the positive effects that could be demonstrated for the use of BIS monitors.\n\nTherefore, the aim of the investigator's study is to investigate the clinical relevance of interpreting the raw frontal EEG in addition to only using the BIS index for titrating intravenous anaesthetics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing in-hospital laparoscopic abdominal surgery with general anaesthesia using Propofol based on the Schnider model (target controlled infusion)42, 43\n* Minimal duration of surgery of 60 minutes\n* Written informed consent\n\nExclusion Criteria:\n\n* Same-day surgery\n* Language barrier\n* Patients under 18 years of age\n* Pregnancy (using a beta-human chorionic gonadotropin (HCG) measurement in a blood sample of women in childbearing age)\n* Allergy to Propofol\n* Administration of hypnotics other than Propofol, such as ketamine or midazolam preoperatively or intraoperatively\n* Known brain pathology, such as seizure disorders, dementia, cerebrovascular disease or brain death'}, 'identificationModule': {'nctId': 'NCT04105660', 'briefTitle': 'Electroencephalogram (EEG) in General Anaesthesia - More Than Only a Bispectral Index (BIS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Recovery From Propofol Anaesthesia Guided by Frontal EEG Wave Analysis Compared to Bispectral Index Monitoring Alone in Laparoscopic Surgery: A Multicentre Double-blind Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2019-00132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'EEG monitoring in addition to standard monitoring (clinical parameters and BIS index)', 'interventionNames': ['Other: Training for EEG monitoring', 'Other: Standard monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Standard monitoring including clinical parameters and BIS index', 'interventionNames': ['Other: Standard monitoring']}], 'interventions': [{'name': 'Training for EEG monitoring', 'type': 'OTHER', 'description': 'Training for reading EEG curves during anaesthesia', 'armGroupLabels': ['Intervention arm']}, {'name': 'Standard monitoring', 'type': 'OTHER', 'description': 'Standard monitoring including clinical parameters and BIS index', 'armGroupLabels': ['Control arm', 'Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Chur', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Graubünden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Clinic of Anaesthesiology', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Salome Dell-Kuster, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Christoph S Burkhart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital Graubünden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Deidentified participant data will be available upon reasonable request from the last authors of this publication (Christoph S. Burkhart, ORCID 0000-0002-9288-117X and Salome Dell-Kuster, ORCID 0000-0001-7219-7138)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cantonal Hospital of Graubünden, Chur, Switzerland', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}