Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-04 @ 5:10 PM
Study NCT ID:
NCT01795495
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2013-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methadone vs Magnesium in Spinal Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'David.Martin@nationwidechildrens.org', 'phone': '6147224200', 'title': 'David Martin, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.\n\nRemifentanil', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Remifentanil Plus Methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.\n\nMethadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Remifentanil Plus Magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.\n\nMagnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra- and Post-operative Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.\n\nRemifentanil'}, {'id': 'OG001', 'title': 'Remifentanil Plus Methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.\n\nMethadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia'}, {'id': 'OG002', 'title': 'Remifentanil Plus Magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.\n\nMagnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intra-operative and 24 hours post-operatively', 'description': 'To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.\n\nRemifentanil'}, {'id': 'OG001', 'title': 'Remifentanil Plus Methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.\n\nMethadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia'}, {'id': 'OG002', 'title': 'Remifentanil Plus Magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.\n\nMagnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operatively to 24 hours', 'description': 'VAS pain score - 0 being no pain and 10 being worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.\n\nRemifentanil'}, {'id': 'FG001', 'title': 'Remifentanil Plus Methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.\n\nMethadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia'}, {'id': 'FG002', 'title': 'Remifentanil Plus Magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.\n\nMagnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.\n\nRemifentanil'}, {'id': 'BG001', 'title': 'Remifentanil Plus Methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.\n\nMethadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia'}, {'id': 'BG002', 'title': 'Remifentanil Plus Magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.\n\nMagnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '15.3', 'spread': '1.9', 'groupId': 'BG002'}, {'value': '15.0', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '5.6', 'groupId': 'BG002'}, {'value': '22.6', 'spread': '5.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2013-02-18', 'resultsFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-06', 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra- and Post-operative Pain Relief', 'timeFrame': 'Intra-operative and 24 hours post-operatively', 'description': 'To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Scores', 'timeFrame': 'Post-operatively to 24 hours', 'description': 'VAS pain score - 0 being no pain and 10 being worst pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal Fusion', 'Scoliosis', 'Methadone', 'Magnesium', 'Adolescents', 'Back Surgery'], 'conditions': ['Idiopathic Scoliosis']}, 'referencesModule': {'references': [{'pmid': '22978825', 'type': 'BACKGROUND', 'citation': 'Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14.'}, {'pmid': '22037641', 'type': 'BACKGROUND', 'citation': 'Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.'}, {'pmid': '20418538', 'type': 'BACKGROUND', 'citation': 'Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.'}, {'pmid': '16670112', 'type': 'BACKGROUND', 'citation': 'Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. doi: 10.1093/bja/ael085. Epub 2006 May 2.'}, {'pmid': '12562408', 'type': 'BACKGROUND', 'citation': 'Levaux Ch, Bonhomme V, Dewandre PY, Brichant JF, Hans P. Effect of intra-operative magnesium sulphate on pain relief and patient comfort after major lumbar orthopaedic surgery. Anaesthesia. 2003 Feb;58(2):131-5. doi: 10.1046/j.1365-2044.2003.02999.x.'}, {'pmid': '30078167', 'type': 'DERIVED', 'citation': 'Martin DP, Samora WP 3rd, Beebe AC, Klamar J, Gill L, Bhalla T, Veneziano G, Thung A, Tumin D, Barry N, Rice J, Tobias JD. Analgesic effects of methadone and magnesium following posterior spinal fusion for idiopathic scoliosis in adolescents: a randomized controlled trial. J Anesth. 2018 Oct;32(5):702-708. doi: 10.1007/s00540-018-2541-5. Epub 2018 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.\n\nThe current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response.\n\nThe purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis\n* American Society of Anesthesiologist (ASA) physical status I or II\n* Parents/Guardian willing and able to authorize informed consent\n* Patients willing and able to authorize assent\n\nExclusion Criteria:\n\n* Patients presenting with neuromuscular scoliosis\n* Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment\n* Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder'}, 'identificationModule': {'nctId': 'NCT01795495', 'briefTitle': 'Methadone vs Magnesium in Spinal Fusion', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium', 'orgStudyIdInfo': {'id': 'IRB13-0036'}, 'secondaryIdInfos': [{'id': 'Active', 'type': 'OTHER_GRANT', 'domain': "Nationwide Children's Hospital Intramural Grant - 292913"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'This arm will receive remifentanil alone as is the current practice.', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Remifentanil plus methadone', 'description': 'This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.', 'interventionNames': ['Drug: Methadone hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Remifentanil plus magnesium', 'description': 'This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.', 'interventionNames': ['Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Methadone hydrochloride', 'type': 'DRUG', 'otherNames': ['Methadone'], 'description': 'This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia', 'armGroupLabels': ['Remifentanil plus methadone']}, {'name': 'Magnesium Sulfate', 'type': 'DRUG', 'otherNames': ['Magnesium'], 'description': 'This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).', 'armGroupLabels': ['Remifentanil plus magnesium']}, {'name': 'Remifentanil', 'type': 'DRUG', 'armGroupLabels': ['Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'David P. Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'David P. Martin', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}