Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-16 @ 3:44 PM
Study NCT ID:
NCT02771912
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of self administered bolus', 'timeFrame': 'One day'}]}, 'conditionsModule': {'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be operated of cataract under topical anesthesia\n\nExclusion Criteria:\n\n* Contra-indication to sedation\n* Complicated cataract\n* Hypersensitivity to propofol, known or suspected hypersensitivity to egg phospholipid, soybean or peanut protein\n* State of acute shock, severe dyslipidemia, severe liver failure, serious bleeding disorders\n* Comprehension and language impairment\n* Written and signed informed consent by the patient to participate in the study'}, 'identificationModule': {'nctId': 'NCT02771912', 'acronym': 'CATARSIS', 'briefTitle': 'Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia', 'orgStudyIdInfo': {'id': 'ILC_2016_5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'Infusion containing Propofol lipuro® 2% at a concentration of 2 mg/ml (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Propofol lipuro® 2 %).\n\nSelf administration of propofol via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution (0.25 mg/kg propofol) with a programmed lock-out period of 3 minutes.\n\nMaximal dose of propofol : 1,25 mg/kg corresponding to 5mg/kg/h.', 'interventionNames': ['Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intralipid', 'description': 'Infusion containing Intralipid® (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Intralipid® 20%) to obtain an identical aspect to that of propofol infusion.\n\nSelf administration via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution with a programmed lock-out period of 3 minutes.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol lipuro 2%'], 'description': 'Propofol and excipients', 'armGroupLabels': ['Propofol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Intralipid'], 'description': 'Qualitative composition of Propofol lipuro 2% excipients', 'armGroupLabels': ['Intralipid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}