Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT02327195
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2014-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
General Anesthesia Emergence Induced by Methylphenidate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicoleta.stoicea@osumc.edu', 'phone': '614-293-3559', 'title': 'Nicoleta Stoicea', 'organization': 'The Ohio State University Wexner Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '34 days', 'description': 'Continued multi-modal monitoring and vigilance with regard to any suspected adverse effects, including cardiovascular effects will help to fill the informational gap with regards to unknown cardiovascular side effects, emergence delirium incidence and perioperatory awareness.Due to the potential risk of drug related serious side effects, any clinical evidence of a serious adverse event will place the study on clinical hold until a full assessment and decision is made by the responsible parties.', 'eventGroups': [{'id': 'EG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'seriousEvents': [{'term': 'Mild QTc prolongation', 'notes': 'Mild QTc prolongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Emergence Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the moment when isoflurane infusion is stopped until time of extubation', 'description': 'After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 24 Hours Postoperatively', 'description': 'Efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Dose Escalation Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)'}, {'id': 'OG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery', 'description': 'Assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)'}, {'id': 'FG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery\n\nMethylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)'}, {'id': 'BG001', 'title': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery\n\nPlacebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '40'}, {'value': '36', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '43'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-20', 'size': 438600, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-26T12:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2014-12-16', 'resultsFirstSubmitDate': '2018-12-26', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-02', 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence Time', 'timeFrame': 'From the moment when isoflurane infusion is stopped until time of extubation', 'description': 'After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Experienced Postoperative Nausea and Vomiting', 'timeFrame': 'First 24 Hours Postoperatively', 'description': 'Efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)'}, {'measure': 'Opioid Dose Escalation Prevention', 'timeFrame': 'During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery', 'description': 'Assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Delayed Emergence From Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.', 'detailedDescription': 'Based on this significant arousal stimulatory effect, the investigators hypothesize that methylphenidate (inhibitor of dopamine and norepinephrine transporters) decreases the emergence time from isoflurane general anesthesia.\n\nPRIMARY OBJECTIVE:\n\nTo assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.\n\nSECONDARY OBJECTIVES:\n\n* To assess the efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)\n* To assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).\n\nStudy Population: Adult patients at Ohio State University Wexner Medical Center - Sports Medicine, aged between 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient) or II (patients with mild systemic disease; no functional limitation) who are scheduled to undergo hip arthroscopic surgery - same day discharge - under isoflurane general anesthesia.\n\nSingle-center, prospective, randomized, double-blind, placebo-controlled trial involving 54 subjects scheduled to undergo arthroscopic orthopedic surgery under isoflurane general anesthesia at The Ohio State University Wexner Medical Center (OSUWMC) - University Hospital East. Eligible subjects that provide voluntary and written informed consent will be included in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 to 65 years of age\n* ASA I or II\n* Capable and willing to consent\n* Participants literate in English language\n\nExclusion Criteria:\n\n* ADHD with current use of methylphenidate\n* Hypersensitivity to methylphenidate\n* ASA III, IV or V\n* Patients with severe visual or auditory disorder\n* Illiteracy\n* Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia\n* Tics or Tourette's syndrome\n* Glaucoma\n* Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter), myocardial infarction\n* Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI (Selegiline)\n* Subjects who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery\n* Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)"}, 'identificationModule': {'nctId': 'NCT02327195', 'acronym': 'MPOrtho', 'briefTitle': 'General Anesthesia Emergence Induced by Methylphenidate', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate', 'orgStudyIdInfo': {'id': '2013H0296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylphenidate', 'description': 'Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery', 'interventionNames': ['Drug: Methylphenidate HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 mg Placebo (PO) given 2 hours prior to surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylphenidate HCl', 'type': 'DRUG', 'otherNames': ['Concerta', 'Daytrana', 'Methylin', 'Ritalin'], 'description': 'Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)', 'armGroupLabels': ['Methylphenidate']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (PO)'], 'description': '20 mg of placebo (PO) will be given 2 hours prior to surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Nicoleta Stoicea, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicoleta Stoicea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Scientist, Adj. Assistant professor', 'investigatorFullName': 'Nicoleta Stoicea', 'investigatorAffiliation': 'Ohio State University'}}}}