Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT01118260
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2010-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006965', 'term': 'Hyperplasia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '4 hours', 'description': 'Patient satisfaction was measured asking the patient about satisfaction with anaesthesia using a 5-point Linkert scale: totally satisfied - satisfied - neither satisfied nor dissatisfied - dissatisfied - totally dissatisfied Time frame: Start anaesthesia to end post anaesthestic care unit'}], 'secondaryOutcomes': [{'measure': 'time in PACU', 'timeFrame': '4 hours', 'description': 'period in post anaesthetic care unit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostata hyperplasia', 'transurethral resection', 'TIVA', 'spinal anaesthesia'], 'conditions': ['Prostate', 'Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection', 'detailedDescription': 'Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* signed informed consent\n* elective transurethral prostata resection\n\nExclusion Criteria:\n\n* ASA more than 3\n* kidney disease, liver disease\n* intolerance against bupivacaine, fentanyl, propofol og remifentanil\n* chronic pulmonary disease\n* dementia'}, 'identificationModule': {'nctId': 'NCT01118260', 'acronym': 'TURPS', 'briefTitle': 'Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection', 'organization': {'class': 'OTHER', 'fullName': 'Asker & Baerum Hospital'}, 'officialTitle': 'TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection', 'orgStudyIdInfo': {'id': '2004-002672-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TIVA', 'description': 'Total intravenous anaesthesia (TIVA) with propofol and remifentanil', 'interventionNames': ['Procedure: total intravenous anaesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal', 'description': 'Spinal anaesthesia with bupivacaine and fentanyl', 'interventionNames': ['Procedure: spinal anaesthesia']}], 'interventions': [{'name': 'total intravenous anaesthesia', 'type': 'PROCEDURE', 'description': 'propofol and remifentanil', 'armGroupLabels': ['TIVA']}, {'name': 'spinal anaesthesia', 'type': 'PROCEDURE', 'description': 'bupivacaine and fentanyl', 'armGroupLabels': ['Spinal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1309', 'city': 'Rud', 'country': 'Norway', 'facility': 'Asker & Baerum Hospital', 'geoPoint': {'lat': 60.43333, 'lon': 11.63333}}], 'overallOfficials': [{'name': 'Vegard Dahl, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asker & Baerum Hospital'}, {'name': 'Elisabet Andersson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asker & Baerum Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asker & Baerum Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. med. Vegard Dahl', 'oldOrganization': 'Asker & Baerum Hospital, Vestre Viken HF'}}}}