Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-23 @ 6:37 AM
Study NCT ID:
NCT02410460
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetics in Rhytidoplasty - A Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-04-11', 'releaseDate': '2016-03-14'}], 'estimatedResultsFirstSubmitDate': '2016-03-14'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012601', 'term': 'Scopolamine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D015738', 'term': 'Famotidine'}, {'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (QOR-40/VAS)', 'timeFrame': '1 week', 'description': 'Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7'}, {'measure': 'Nausea/vomiting (QOR-40)', 'timeFrame': '24 hours', 'description': 'Quality of recovery score (QOR-40) in PACU and POD#1'}, {'measure': 'Time to awakening', 'timeFrame': '4 hours', 'description': 'staff recorded'}, {'measure': 'Time to discharge', 'timeFrame': '4 hours', 'description': 'staff recorded'}, {'measure': 'Overall feeling of well-being (QOR-40/VAS)', 'timeFrame': '1 week', 'description': 'Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7'}], 'secondaryOutcomes': [{'measure': 'Cost (reported as a mean)', 'timeFrame': '1 day', 'description': 'comparison between two groups (reported as a mean)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rhytidoplasty']}, 'referencesModule': {'references': [{'pmid': '25906190', 'type': 'DERIVED', 'citation': 'Jones KA, LaFerriere KA. Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, double-blind, randomized comparison study of different anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring (PKA-BIS) rather than general anesthesia, without increasing intra-operative time, side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift surgery performed by the principal investigator will participate.', 'detailedDescription': "PKA-BIS arm receives the following medications:\n\nclonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)\n\nGeneral Anesthesia arm receives the following medications:\n\nPre-operatively:\n\nPepcid 20mg Scopolamine 1.5mg transdermal patch Versed 2mg Zofran 8mg Reglan 10mg Glycopyrrolate - dose determined by anesthesiologist\n\nDuring the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic also varied based on anesthesiologist's choice)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Female\n* 18 years of age or older\n* Undergoing elective rhytidoplasty\n\nExclusion criteria:\n\n* Male\n* Under 18 years old\n* Pregnant or breastfeeding\n* Medically unfit to undergo surgery\n* Undergoing brow-lift in conjunction with rhytidoplasty (due to the inability to properly secure the BIS monitor as it would lie within the surgical field)'}, 'identificationModule': {'nctId': 'NCT02410460', 'briefTitle': 'Anesthetics in Rhytidoplasty - A Comparison Study', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Facial Plastic Surgery Center'}, 'officialTitle': 'The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study', 'orgStudyIdInfo': {'id': 'MercyFPSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PKA-BIS (intravenous anesthesia)', 'description': 'Received the following medications:\n\nclonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)', 'interventionNames': ['Drug: clonidine', 'Drug: glycopyrrolate', 'Drug: propofol', 'Drug: ketamine', 'Drug: marcaine', 'Drug: lidocaine']}, {'type': 'OTHER', 'label': 'Inhalational anesthesia', 'description': "Received the following:\n\nPre-operatively:\n\nfamotidine 20mg scopolamine 1.5mg transdermal patch midazolam 2mg ondansetron 8mg metoclopramide 10mg glycopyrrolate - dose determined by anesthesiologist\n\nDuring the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic - desfluorane vs. sevofluorane - also varied based on anesthesiologist's choice)", 'interventionNames': ['Drug: clonidine', 'Drug: marcaine', 'Drug: scopolamine', 'Drug: midazolam', 'Device: ondansetron', 'Drug: metoclopramide', 'Drug: glycopyrrolate', 'Drug: lidocaine', 'Drug: famotidine', 'Drug: desflurane', 'Drug: sevoflurane']}], 'interventions': [{'name': 'clonidine', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia', 'PKA-BIS (intravenous anesthesia)']}, {'name': 'glycopyrrolate', 'type': 'DRUG', 'armGroupLabels': ['PKA-BIS (intravenous anesthesia)']}, {'name': 'propofol', 'type': 'DRUG', 'armGroupLabels': ['PKA-BIS (intravenous anesthesia)']}, {'name': 'ketamine', 'type': 'DRUG', 'armGroupLabels': ['PKA-BIS (intravenous anesthesia)']}, {'name': 'marcaine', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia', 'PKA-BIS (intravenous anesthesia)']}, {'name': 'scopolamine', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'midazolam', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'ondansetron', 'type': 'DEVICE', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'metoclopramide', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'glycopyrrolate', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia', 'PKA-BIS (intravenous anesthesia)']}, {'name': 'famotidine', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'desflurane', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}, {'name': 'sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Inhalational anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Facial Plastic Surgery Center', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Facial Plastic Surgery Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristin A. Jones', 'investigatorAffiliation': 'Mercy Facial Plastic Surgery Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-14', 'type': 'RELEASE'}, {'date': '2016-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kristin A. Jones, Principal Investigator, Mercy Facial Plastic Surgery Center'}}}}