Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT03553758
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
EEG Studies of Ketamine General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oluwaseun.akeju@mgh.harvard.edu', 'phone': '617-724-7200', 'title': 'Dr. Oluwaseun Johnson-Akeju', 'organization': 'Massachusetts General Hospital DACCPM'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From initiation of anesthesia during the first study visit to completion of the study visit, which was approximately 2 hours.', 'description': 'Adverse events and other events were determined by regular investigator assessment and self-reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nSubjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Pain Intensity Pre- and Post-Ketamine Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine EEG Dynamics', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nSubjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."}], 'classes': [{'title': 'Pre-Ketamine', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '30 minutes Post-Ketamine', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': '60 minutes Post-Ketamine', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': '75 minutes Post-Ketamine', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': '120 minutes Post-Ketamine', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 125 minutes', 'description': 'Average Pain Intensity prior to ketamine induction, 30 minutes post ketamine, 60 minutes post ketamine, 75 minutes post ketamine, and 120 minutes post ketamine. PROMIS Pain Intensity 1a was used to assess pain delivered by a pre-calibrated pain cuff. Scale of 0 (no pain) to 10 (worst imaginable pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient did not complete assessments after recovery of responsiveness.'}, {'type': 'SECONDARY', 'title': 'Average Dissociation States Score Pre- and Post-Ketamine Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nKetamine: Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."}], 'classes': [{'title': 'Pre-Ketamine', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': '60 minutes post-ketamine', 'categories': [{'measurements': [{'value': '22.1', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': '75 minutes post-ketamine', 'categories': [{'measurements': [{'value': '14.3', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': '120 minutes post-ketamine', 'categories': [{'measurements': [{'value': '5.2', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'About 125 minutes', 'description': 'Patients were assessed for dissociation states prior to the induction of ketamine and at 60 minutes, 75 minutes, and 120 minutes after Ketamine was administered. The Clinician Administered Dissociation States Scale was used to measure dissociation. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient did not perform assessments after recovery of responsiveness.'}, {'type': 'SECONDARY', 'title': 'Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nSubjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '17.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'About 60 minutes', 'description': 'Midazolam was administered approximately 60 minutes after the administration of Ketamine in order to reduce the effects of Ketamine on dissociation. Dissociation was measured using the Clinician Administered Dissociative States Scale. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation). The difference of the mean Clinician Administered Dissociative States Scale before and after Midazolam administration was found.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient did not complete assessments after recovery of responsiveness.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nSubjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Completed Screening Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': "15 subjects undergoing ketamine general anesthesia.\n\nSubjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '3.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '1 patient was enrolled in the study, but did not complete any study activities.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 207855, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-08T14:45', 'hasProtocol': False}, {'date': '2018-05-11', 'size': 194314, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T07:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2018-04-05', 'resultsFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-14', 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Pain Intensity Pre- and Post-Ketamine Induction', 'timeFrame': 'Approximately 125 minutes', 'description': 'Average Pain Intensity prior to ketamine induction, 30 minutes post ketamine, 60 minutes post ketamine, 75 minutes post ketamine, and 120 minutes post ketamine. PROMIS Pain Intensity 1a was used to assess pain delivered by a pre-calibrated pain cuff. Scale of 0 (no pain) to 10 (worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Average Dissociation States Score Pre- and Post-Ketamine Induction', 'timeFrame': 'About 125 minutes', 'description': 'Patients were assessed for dissociation states prior to the induction of ketamine and at 60 minutes, 75 minutes, and 120 minutes after Ketamine was administered. The Clinician Administered Dissociation States Scale was used to measure dissociation. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation).'}, {'measure': 'Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration', 'timeFrame': 'About 60 minutes', 'description': 'Midazolam was administered approximately 60 minutes after the administration of Ketamine in order to reduce the effects of Ketamine on dissociation. Dissociation was measured using the Clinician Administered Dissociative States Scale. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation). The difference of the mean Clinician Administered Dissociative States Scale before and after Midazolam administration was found.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': "We are doing this research study to find out how and where ketamine acts in the brain. Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by putting you in an unconscious state). We will look at the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG). We will assess how it impacts patient's pain responses.", 'detailedDescription': 'In this trial, participants will be given ketamine at a high enough dosage to induce general anesthesia. EEG recording will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after ketamine induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between the ages of 18 to 45\n* Normal body weight and habitus, BMI less than or equal to 30\n* Non-smoker\n* American Society of Anesthesiologists (ASA) physical status classification P1\n\nExclusion Criteria:\n\n* Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension\n* Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath\n* Hepatic: hepatitis, jaundice, ascites\n* Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis\n* Gastrointestinal: esophageal reflux, hiatal hernia, ulcer\n* Endocrine: diabetes, thyroid disease\n* Renal: acute or chronic severe renal insufficiency\n* Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy\n* Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia\n* Psychiatric: history or treatment for an active psychiatric problem, depression\n* Reproductive: pregnancy, breast-feeding\n* Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort\n* Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, midazolam"}, 'identificationModule': {'nctId': 'NCT03553758', 'briefTitle': 'EEG Studies of Ketamine General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Electroencephalogram Studies of Induction and Recovery From Ketamine-Induced General Anesthesia', 'orgStudyIdInfo': {'id': '2018P000417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': '15 subjects undergoing ketamine general anesthesia.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': "Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.", 'armGroupLabels': ['Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesia', 'investigatorFullName': 'Oluwaseun Johnson-Akeju, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}