Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT03401606
Status:
TERMINATED
Last Update Posted:
2018-01-17
First Post:
2015-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Sedation for Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'whyStopped': 'a respiratory depression in remifentanyl group', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hypotension', 'timeFrame': 'Intraoperative', 'description': 'Systolic blood pressure below 90 mmHg'}, {'measure': 'Respiratory depression', 'timeFrame': 'Intraoperative', 'description': 'Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation'}, {'measure': 'Oxygen desaturation', 'timeFrame': 'Intraoperative', 'description': 'Hemoglobin oxygen saturation below 90%'}, {'measure': 'Internation', 'timeFrame': 'Intraoperative', 'description': 'Inpatient treatment'}], 'primaryOutcomes': [{'measure': 'Surgeon and patient satisfaction', 'timeFrame': 'Intraoperative', 'description': 'It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Intraoperative', 'description': 'Beats per minute (bpm)'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Intraoperative', 'description': 'Millimeters of mercury (mmHg)'}, {'measure': 'Hemoglobin oxygen saturation', 'timeFrame': 'Intraoperative', 'description': 'Oxygen saturation (%)'}, {'measure': 'Surgery duration', 'timeFrame': 'Intraoperative', 'description': 'Minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedation', 'dexmedetomidine', 'remifentanil', 'cataract surgery', 'surgeon satisfaction', 'patient satisfaction'], 'conditions': ['Failed Conscious Sedation During Procedure']}, 'descriptionModule': {'briefSummary': 'This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation', 'detailedDescription': 'This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has cataract,\n* subject older than 18 years,\n* local anesthesia and sedation.\n\nExclusion Criteria:\n\n* general anesthesia,\n* history of consumption of sedatives.'}, 'identificationModule': {'nctId': 'NCT03401606', 'briefTitle': 'Controlled Sedation for Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universitaria de Ciencias de la Salud'}, 'officialTitle': 'Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation', 'orgStudyIdInfo': {'id': '516-3847-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.', 'interventionNames': ['Drug: remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'description': 'remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished', 'armGroupLabels': ['Remifentanil']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Luis Muñoz, Md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion universitaria de ciencias de la salud'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universitaria de Ciencias de la Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}