Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 9:53 PM
Study NCT ID:
NCT02733757
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D003975', 'term': 'Diazepam'}], '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': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'renatogomez2000@yahoo.com.br', 'phone': '553134099760', 'title': 'Dr Renato Gomez', 'organization': 'Universidade federal de Minas Gerais'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': "Sub-Tenon's Group Control", 'description': '2% Lidocaine without epinephrine', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': "Sub-Tenon's Group Clonidine", 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Peribulbar Group Control', 'description': '2% Lidocaine without epinephrine', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Peribulbar Group Clonidine', 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Sub-Tenon's Group Control", 'description': '2% Lidocaine without epinephrine'}, {'id': 'OG001', 'title': "Sub-Tenon's Group Clonidine", 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}, {'id': 'OG002', 'title': 'Peribulbar Group Control', 'description': '2% Lidocaine without epinephrine'}, {'id': 'OG003', 'title': 'Peribulbar Group Clonidine', 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '3', 'groupId': 'OG000'}, {'value': '16', 'spread': '4', 'groupId': 'OG001'}, {'value': '19', 'spread': '3', 'groupId': 'OG002'}, {'value': '16', 'spread': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 10 minutes before the surgery procedure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Sub-Tenon's Group Control", 'description': '2% Lidocaine without epinephrine'}, {'id': 'FG001', 'title': "Sub-Tenon's Group Clonidine", 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}, {'id': 'FG002', 'title': 'Peribulbar Group Control', 'description': '2% Lidocaine without epinephrine'}, {'id': 'FG003', 'title': 'Peribulbar Group Clonidine', 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': "Sub-Tenon's Group Control", 'description': '2% Lidocaine without epinephrine'}, {'id': 'BG001', 'title': "Sub-Tenon's Group Clonidine", 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}, {'id': 'BG002', 'title': 'Peribulbar Group Control', 'description': '2% Lidocaine without epinephrine'}, {'id': 'BG003', 'title': 'Peribulbar Group Clonidine', 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg\n\nClonidine: Clonidine 1 µg/kg plus 2% lidocaine'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '12', 'groupId': 'BG000'}, {'value': '60', 'spread': '13', 'groupId': 'BG001'}, {'value': '64', 'spread': '14', 'groupId': 'BG002'}, {'value': '62', 'spread': '12', 'groupId': 'BG003'}, {'value': '63', 'spread': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2016-03-15', 'resultsFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2016-04-08', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-11', 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': 'Within 10 minutes before the surgery procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clonidine', "Sub-Tenon's and Peribulbar block", 'IOP', 'OPP', 'OPA'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '11524193', 'type': 'BACKGROUND', 'citation': "Pianka P, Weintraub-Padova H, Lazar M, Geyer O. Effect of sub-Tenon's and peribulbar anesthesia on intraocular pressure and ocular pulse amplitude. J Cataract Refract Surg. 2001 Aug;27(8):1221-6. doi: 10.1016/s0886-3350(01)00797-0."}, {'pmid': '11423451', 'type': 'BACKGROUND', 'citation': 'Watkins R, Beigi B, Yates M, Chang B, Linardos E. Intraocular pressure and pulsatile ocular blood flow after retrobulbar and peribulbar anaesthesia. Br J Ophthalmol. 2001 Jul;85(7):796-8. doi: 10.1136/bjo.85.7.796.'}, {'pmid': '23797624', 'type': 'BACKGROUND', 'citation': "Cabral SA, Carraretto AR, Brocco MC, Abreu Baptista JF, Gomez RS. Effect of clonidine added to lidocaine for sub-Tenon's (episcleral) anesthesia in cataract surgery. J Anesth. 2014 Feb;28(1):70-5. doi: 10.1007/s00540-013-1660-2."}]}, 'descriptionModule': {'briefSummary': "Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.", 'detailedDescription': "In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 30 and 86 years old\n* Both genders\n* Physical status ASA (American Society of Anesthesiologists) I and II\n* Cooperative patients undergoing cataract surgery by phacoemulsification\n\nExclusion Criteria:\n\n* Patients with communication difficulties\n* Allergic to any medication protocol\n* Chronic therapy with clonidine\n* In use of antihypertensive medication\n* Diabetes\n* Glaucoma\n* Previous surgery in the same eye\n* Abnormalities in coagulation'}, 'identificationModule': {'nctId': 'NCT02733757', 'briefTitle': "Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': "Effects of Clonidine Added to Lidocaine in Sub-Tenon's and Peribulbar Anesthesia: Assessments of Intraocular Pressure (IOP), Ocular Perfusion Pressure (OPP) and Ocular Pulse Amplitude (OPA)", 'orgStudyIdInfo': {'id': 'CAAE - 03409512.2.0000.5149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': "Sub-Tenon's group control", 'description': '2% Lidocaine without epinephrine'}, {'type': 'EXPERIMENTAL', 'label': "Sub-Tenon's group clonidine", 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg', 'interventionNames': ['Drug: Clonidine']}, {'type': 'NO_INTERVENTION', 'label': 'Peribulbar group control', 'description': '2% Lidocaine without epinephrine'}, {'type': 'EXPERIMENTAL', 'label': 'Peribulbar group clonidine', 'description': '2% Lidocaine without epinephrine plus clonidine 1 µg/kg', 'interventionNames': ['Drug: Clonidine']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['Atensine'], 'description': 'Clonidine 1 µg/kg plus 2% lidocaine', 'armGroupLabels': ['Peribulbar group clonidine', "Sub-Tenon's group clonidine"]}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sigmar Cabral, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Espírito Santo, Vitória'}, {'name': 'Renato Gomez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Minas Gerais, Belo Horizonte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Espirito Santo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of surgery department of the medical school of the Federal University of Minas Gerais', 'investigatorFullName': 'Renato Santiago Gomez', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}