Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-27 @ 2:37 AM
Study NCT ID:
NCT02469961
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pgupta@maimonidesmed.org', 'phone': '718-283-7189', 'title': 'Piyush Gupta, Director of clinical affairs', 'organization': 'Maimonides Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There was no limitations'}}, 'adverseEventsModule': {'timeFrame': 'Study was conducted for one year and four months', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine\n\nDexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol\n\nPropofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Need an Airway Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Number of patients required airway manipulation'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Number of patients required airway manipulations'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'airway manipulation or repositioning: apnea, oral airway, adjust head', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Anesthesia Care Unit (PACU) Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine\n\nDexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol\n\nPropofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'spread': '12', 'groupId': 'OG000'}, {'value': '126', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation', 'description': 'length of stay in minutes in the Post Anesthesia Care Unit before discharge', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Have Either Bradycardia or Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': 'Patients who received Propofol'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Patients who received Dexmedetomidine'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'Number of participants observed with Bradycardia or Hypotension who required intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who had Bradycardia or hypotension'}, {'type': 'SECONDARY', 'title': 'Total Narcotic Used by Each Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine\n\nDexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol\n\nPropofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '9', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents', 'unitOfMeasure': 'Microgram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidne', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine\n\nDexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}, {'id': 'FG001', 'title': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol\n\nPropofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine\n\nDexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}, {'id': 'BG001', 'title': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol\n\nPropofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine\n\nInterscalene block: Interscalene block is used for the main anesthetic for the case'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '45'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2015-06-03', 'resultsFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-30', 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Need an Airway Intervention.', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'airway manipulation or repositioning: apnea, oral airway, adjust head'}], 'secondaryOutcomes': [{'measure': 'Post Anesthesia Care Unit (PACU) Length of Stay', 'timeFrame': 'Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation', 'description': 'length of stay in minutes in the Post Anesthesia Care Unit before discharge'}, {'measure': 'Number of Participants That Have Either Bradycardia or Hypotension', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'Number of participants observed with Bradycardia or Hypotension who required intervention'}, {'measure': 'Total Narcotic Used by Each Participant', 'timeFrame': 'Participants will be followed from the start of sedation until discharge: approximately 3-5 hr', 'description': 'the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '24219821', 'type': 'RESULT', 'citation': 'Mehta PP, Kochhar G, Kalra S, Maurer W, Tetzlaff J, Singh G, Lopez R, Sanaka MR, Vargo JJ. Can a validated sleep apnea scoring system predict cardiopulmonary events using propofol sedation for routine EGD or colonoscopy? A prospective cohort study. Gastrointest Endosc. 2014 Mar;79(3):436-44. doi: 10.1016/j.gie.2013.09.022. Epub 2013 Nov 9.'}, {'pmid': '11056756', 'type': 'RESULT', 'citation': 'Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.\n\nThe primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study.\n\nOur hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol', 'detailedDescription': "The anesthesia provided during shoulder surgery commonly uses a combination of regional and intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use of it problematic in cases where the head of the patient is less accessible to the anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved drug, which has a very stable cardiovascular and respiratory profile. It has been successfully used for Neurological and Vascular cases and in Intensive care units. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this study. Using a computer program the participants will be randomized into two equal groups to receive either Dexmedetomidine or Propofol.\n\nThe standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.\n\nDexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0 mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained with Propofol at 50-120mcg/kg/min, during the surgery.\n\nIn each group the investigators will record the incidence of respiratory depression/hypoxia, hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge time, the need for postoperative pain medication, post operative complications, like nausea/vomiting.\n\nSignificant differences between the two groups will be evaluated using unpaired t-test for numerical variables, and Chi-square test or Z test for categorical variables.\n\nThe investigators hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants scheduled for shoulder arthroscopies in the beach chair sitting position.\n\nParticipants who received a successful interscalene block.\n\nExclusion Criteria:\n\nFailed interscalene block. Refusal to participate in the study. Allergy to the study drugs. Participants that need a secure airway.'}, 'identificationModule': {'nctId': 'NCT02469961', 'acronym': 'TIVA', 'briefTitle': 'Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block', 'organization': {'class': 'OTHER', 'fullName': 'Maimonides Medical Center'}, 'officialTitle': 'Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position', 'orgStudyIdInfo': {'id': '10/07/VA07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine', 'description': 'Participants will receive an interscalene block and be sedated with dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine', 'Other: Interscalene block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Participants will receive an interscalene block and be sedated with propofol', 'interventionNames': ['Drug: Propofol', 'Other: Interscalene block']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['diprivan'], 'description': 'Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine', 'armGroupLabels': ['Propofol']}, {'name': 'Interscalene block', 'type': 'OTHER', 'description': 'Interscalene block is used for the main anesthetic for the case', 'armGroupLabels': ['Propofol', 'dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'piyush Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maimonides Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimonides Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Piyush Gupta, MD', 'investigatorAffiliation': 'Maimonides Medical Center'}}}}