Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-19 @ 2:33 AM
Study NCT ID:
NCT04520503
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)'}, {'measure': 'Processed EEG index (PSI; patient state index)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Processed EEG index (PSI; patient state index)'}, {'measure': 'Mean frequency and 95% spectral edge frequency (Hz)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Mean frequency and 95% spectral edge frequency (Hz)'}, {'measure': 'Burst suppression ratio (%)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Burst suppression ratio (%)'}], 'secondaryOutcomes': [{'measure': 'The effect-site concentrations of propofol at loss of consciousness (μg/ml)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'The effect-site concentrations of propofol at loss of consciousness (μg/ml)'}, {'measure': 'The dose of propofol required for loss of consciousness (mg)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'The dose of propofol required for loss of consciousness (mg)'}, {'measure': 'Total amount of propofol used (mg)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Total amount of propofol used (mg)'}, {'measure': 'Time to loss of consciousness (second)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Time to loss of consciousness (second) after the start of induction'}, {'measure': 'Vital sign - blood pressure', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Check blood pressure (mmHg)'}, {'measure': 'Vital sign - heart rate', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Check heart rate (beats per minute)'}, {'measure': 'Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)', 'timeFrame': 'During the induction of anesthesia (up to 15 min)', 'description': 'Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Propofol Overdose of Undetermined Intent']}, 'descriptionModule': {'briefSummary': "The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing general anesthesia\n\nExclusion Criteria:\n\n* Patients undergoing cardiac or brain surgery\n* Patients with neurological deficit or impaired communication (Glasgow Coma Scale \\< 15)\n* Unstable vital sign (cardiogenic, hemorrhagic, septic shock)\n* Patients with eclampsia\n* Patients who administered preoperative anxiolytics\n* Patients who do not require intubation\n* Patients who are considered unsuitable for the study'}, 'identificationModule': {'nctId': 'NCT04520503', 'briefTitle': 'Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol', 'orgStudyIdInfo': {'id': 'pre-induction EEG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre EEG group', 'description': "This cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained", 'interventionNames': ['Drug: Propofol', 'Device: EEG monitoring']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'The dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients.', 'armGroupLabels': ['Pre EEG group']}, {'name': 'EEG monitoring', 'type': 'DEVICE', 'description': 'The processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution.', 'armGroupLabels': ['Pre EEG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (full)', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}