Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-03 @ 2:35 PM
Study NCT ID:
NCT03241004
Status:
TERMINATED
Last Update Posted:
2021-08-20
First Post:
2017-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'change in study staffing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG data', 'timeFrame': '2 hours', 'description': 'change in depth of anesthesia from baseline to two hours'}], 'secondaryOutcomes': [{'measure': 'Subject perception of depth of anesthesia', 'timeFrame': 'within 24 hours of reversal of sedation', 'description': 'post-procedure evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.englewoodhealth.org/for-healthcare-professionals/clinical-research-center', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine if anesthetic depth can be deepened non-pharmacologically through use of sleep masks. This study seeks to demonstrate a relationship between the depth of anesthesia with application of sleep masks intraoperatively and in the critical care setting.', 'detailedDescription': 'Depth of anesthesia will be monitored, both with a standard sleep mask applied and without, in each subject using standard electroencephalogram (EEG) readings via forehead leads and Masimo Sedline 2.0 4-lead EEG monitors.\n\nOR Subjects:\n\nPatients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia, both with and without the sleep mask.\n\nICU Subjects:\n\nPatients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will be used to track the depth of anesthesia, both with and without the sleep mask.\n\nAll Subjects:\n\nIn both settings,once baseline EEG readings are established (30 minutes), EEG data will be recorded and a sleep mask will be applied to the patient for one hour. After one hour (90 minutes), EEG data will be recorded and the sleep mask will be removed. After another hour (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210 minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic agent at each time point will also be recorded.\n\nSubjective perception of depth of anesthesia will be obtained by means of a post-procedure evaluation administered to each subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 18 years of age.\n* Not pregnant.\n\nExclusion Criteria:\n\n* Undergoing surgeries expected to last less than 3 hours.\n* Undergoing vascular or neurosurgical procedures.\n* Patients with history of CVA (Cardiovascular accidents or disease) or other neurological dysfunction.\n* Patients or authorized representatives unable or unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03241004', 'briefTitle': 'Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?', 'organization': {'class': 'OTHER', 'fullName': 'Englewood Hospital and Medical Center'}, 'officialTitle': 'Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?', 'orgStudyIdInfo': {'id': 'E-17-705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Care Unit', 'description': 'Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia.\n\nBaseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.', 'interventionNames': ['Other: Sleep Mask']}, {'type': 'EXPERIMENTAL', 'label': 'Operating Room', 'description': 'Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia.\n\nBaseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded.', 'interventionNames': ['Other: Sleep Mask']}], 'interventions': [{'name': 'Sleep Mask', 'type': 'OTHER', 'description': 'sleep mask applied for two separate 60-minute periods during anesthesia', 'armGroupLabels': ['Intensive Care Unit', 'Operating Room']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}], 'overallOfficials': [{'name': 'Jeff Smok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Englewood Hospital and Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Englewood Hospital and Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}