Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01677351
Status:
UNKNOWN
Last Update Posted:
2012-09-03
First Post:
2012-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Effect of Clonidine for Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D002387', 'term': 'Cataract Extraction'}], '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': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-31', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'antiarrythmic effect', 'timeFrame': '30 minutes before surgery and during the surgery', 'description': 'The antiarrythmic effect will be assessed with the continuous measure by Holter.'}, {'measure': 'blood pressure', 'timeFrame': '30 minutes before and during the surgery', 'description': 'Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.'}], 'primaryOutcomes': [{'measure': 'intensity of pain', 'timeFrame': '30 minutes before surgery, during the surgery', 'description': 'Pain intensity will be assessed by numeric rating scale.'}], 'secondaryOutcomes': [{'measure': 'intraocular pressure', 'timeFrame': '30 minutes and during the surgery', 'description': 'Intra-ocular pressure will be assessed with a manual tonometer of perkins.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clonidine', 'cataract surgery', 'arrythmia', 'anesthesic medication'], 'conditions': ['Pain', 'Arrythmia']}, 'referencesModule': {'references': [{'pmid': '25276415', 'type': 'DERIVED', 'citation': 'Santiago AE, Issy AM, Sakata RK. Effects of preoperative intravenous clonidine in patients undergoing cataract surgery: a double-blind, randomized trial. J Ophthalmol. 2014;2014:346549. doi: 10.1155/2014/346549. Epub 2014 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias for cataract surgery.', 'detailedDescription': 'After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40 until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency, chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of 4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will receive a sterile saline solution dose. Pain intensity will be assessed with the numeric rating scale. The antiarrythmic effect will be assessed with the continuous measure by Holter. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cataract surgery\n* topical anesthesia\n\nExclusion Criteria:\n\n* myocardial ischemia\n* psychiatric disease\n* chronic pain\n* drugs dependency\n* use of beta-blockage channel drugs'}, 'identificationModule': {'nctId': 'NCT01677351', 'briefTitle': 'Assessment of the Effect of Clonidine for Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery', 'orgStudyIdInfo': {'id': 'CEP 0609/01-clonidine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 2: clonidine 4mcg.kg', 'description': 'this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.', 'interventionNames': ['Drug: Clonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1: sterile saline solution', 'description': 'this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['cataract surgery', 'anesthesic drugs'], 'description': '4 mcg.kg-1, 20 minutes before cataract surgery', 'armGroupLabels': ['group 2: clonidine 4mcg.kg']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Group 1: sterile saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Ellen Santiago, investigator', 'role': 'CONTACT', 'email': 'ellensantiago@hotmail.com', 'phone': '55 1 69 9334 4747'}, {'name': 'Ana Ellen Santiago, investigator', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rioko K Sakata, Study Chair', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical resident, principal investigator', 'investigatorFullName': 'Ana Ellen de Queiroz Santiago', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}