Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT02151305
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Hemostasis According to the Anesthetic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D011625', 'term': 'Pterygium'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D014823', 'term': 'Vitreous Hemorrhage'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005130', 'term': 'Eye Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': '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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clotting time of ROTEM', 'timeFrame': '10 minutes before the induction of anesthesia, 1 h after finishing anesthesia'}, {'measure': 'Clot firmness time of ROTEM', 'timeFrame': '10 minutes before the induction of anesthesia, 1 h after finishing anesthesia'}, {'measure': 'Alpha angle of ROTEM', 'timeFrame': '10 minutes before the induction of anesthesia, 1 h after finishing anesthesia'}, {'measure': 'Maximum clot firmness of ROTEM', 'timeFrame': '10 minutes before the induction of anesthesia, 1 h after finishing anesthesia'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin', 'timeFrame': '10 minutes before the induction of anesthesia'}, {'measure': 'Hematocrit', 'timeFrame': '10 minutes before the induction of anesthesia'}, {'measure': 'Platelet count', 'timeFrame': '10 minutes before the induction of anesthesia'}, {'measure': 'International normalized ratio of prothrombin time', 'timeFrame': '10 minutes before the induction of anesthesia'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': '10 minutes before the induction of anesthesia'}, {'measure': 'Fibrinogen', 'timeFrame': '10 minutes before the induction of anesthesia'}]}, 'conditionsModule': {'conditions': ['Cataract', 'Retina Detachment', 'Pterygium', 'Keratitis', 'Vitreous Hemorrhage']}, 'descriptionModule': {'briefSummary': 'We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient scheduled for ophthalmic surgery under general anesthesia\n* American Society of Anesthesiologist physical status I or II\n\nExclusion Criteria:\n\n* hematologic disorder\n* severe anemia\n* liver disease\n* kidney disease\n* taking a medication interfering with hemostasis'}, 'identificationModule': {'nctId': 'NCT02151305', 'briefTitle': 'Different Hemostasis According to the Anesthetic Agents', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.', 'orgStudyIdInfo': {'id': 'ROTEM_anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total intravenous anesthesia group', 'description': 'This group received propofol and remifentanil for the maintenance of general anesthesia.', 'interventionNames': ['Drug: Propofol, remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Inhalation anesthesia group', 'description': 'This group received sevoflurane for the maintenance of general anesthesia.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Propofol, remifentanil', 'type': 'DRUG', 'armGroupLabels': ['Total intravenous anesthesia group']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Inhalation anesthesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pf', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}