Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-02-21 @ 9:53 PM
Study NCT ID:
NCT01740206
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2012-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.Cartabuke@nationwidechildrens.org', 'phone': '614-722-4200', 'title': 'Richard Cartabuke, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '88', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Heart rate prior to anesthetic induction', 'unitOfMeasure': 'BPM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '113.6', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '109.2', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Systolic blood pressure prior to anesthetic induction', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '11', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Diastolic blood pressure prior to anesthetic induction', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '81.7', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Mean blood pressure prior to anesthetic induction', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'mYPAS Measurement in Patients Receiving Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '33'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.\n\nAssessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \\[(A + V + E + S +U)/5\\] x 100. Higher score = more anxiety.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.'}, {'type': 'SECONDARY', 'title': 'mYPAS Measurement in Patients Not Receiving Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'OG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '42'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.\n\nAssessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \\[(A + V + E + S +U)/5\\] x 100. Higher score = more anxiety.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'FG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two subjects with unknown ADHD medication status were excluded from the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Taking ADHD Medication', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.'}, {'id': 'BG001', 'title': 'Patients Not Taking ADHD Medication', 'description': 'Patients who held their stimulant medication the day of surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.25', 'spread': '2.56', 'groupId': 'BG000'}, {'value': '9.35', 'spread': '2.79', 'groupId': 'BG001'}, {'value': '9.32', 'spread': '2.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2012-11-30', 'resultsFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-28', 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'Day 1', 'description': 'Heart rate prior to anesthetic induction'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Day 1', 'description': 'Systolic blood pressure prior to anesthetic induction'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Day 1', 'description': 'Diastolic blood pressure prior to anesthetic induction'}, {'measure': 'Mean Blood Pressure', 'timeFrame': 'Day 1', 'description': 'Mean blood pressure prior to anesthetic induction'}, {'measure': 'mYPAS Measurement in Patients Receiving Midazolam', 'timeFrame': 'Day 1', 'description': 'modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.\n\nAssessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \\[(A + V + E + S +U)/5\\] x 100. Higher score = more anxiety.'}, {'measure': 'mYPAS Measurement in Patients Not Receiving Midazolam', 'timeFrame': 'Day 1', 'description': 'modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.\n\nAssessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = \\[(A + V + E + S +U)/5\\] x 100. Higher score = more anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.\n\nExclusion Criteria:\n\n* Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease.\n* Procedures that entail the likelihood of blood transfusion will be excluded.'}, 'identificationModule': {'nctId': 'NCT01740206', 'briefTitle': 'Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB12-00721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amphetamine and/or methylphenidate', 'description': 'Patients who took their amphetamine and/or methylphenidate the morning of surgery.', 'interventionNames': ['Drug: Amphetamine and/or methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'Hold stimulant medication', 'description': 'Patients who did not take their stimulant medication the morning of surgery.', 'interventionNames': ['Other: Hold stimulant medication']}], 'interventions': [{'name': 'Amphetamine and/or methylphenidate', 'type': 'DRUG', 'description': 'Patients who took their stimulant medication the day of surgery.', 'armGroupLabels': ['Amphetamine and/or methylphenidate']}, {'name': 'Hold stimulant medication', 'type': 'OTHER', 'description': 'Patients who held their stimulant medication the day of surgery.', 'armGroupLabels': ['Hold stimulant medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director of Outpatient Anesthesia Services', 'investigatorFullName': 'Richard Cartabuke', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}