Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 4:18 PM
Study NCT ID:
NCT01743456
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative cognitive decline after bypass surgery', 'timeFrame': 'Six weeks after bypass surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery', 'timeFrame': 'Five days and one year postoperatively'}, {'measure': 'Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery', 'timeFrame': '5days, 6 weeks or 1 year postoperatively'}, {'measure': 'Postoperative Delirium', 'timeFrame': '3-5 days postoperatively'}, {'measure': 'Postoperative central nervous system and myocardial biochemical markers', 'timeFrame': 'up to 48 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative cognitive dysfunction', 'Coronary artery bypass graft surgery', 'Postoperative cognitive improvement', 'Postoperative delirium'], 'conditions': ['Cardiac Bypass Surgery in Adult Patients 65 Years and Older', 'Postoperative Cognitive Dysfunction', 'Postoperative Delirium']}, 'referencesModule': {'references': [{'pmid': '22719840', 'type': 'BACKGROUND', 'citation': 'Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with increased morbidity and mortality. The pathophysiology of POCD is only poorly understood. Causes include hypoperfusion, microemboli and the systemic inflammatory response, which result in a reduction of cerebral oxygen delivery.\n\nCerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen saturation (rSO2).\n\nThe bispectral index (BIS) of the electroencephalogram is widely known to measure depth of anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely low.\n\nThe investigators demonstrated recently that inappropriately high levels of anaesthesia may be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has an effect on postoperative cognitive function in patients undergoing cardiac surgery is unknown.\n\nThe investigators hypothesize that the incidence of POCD in elderly patients (\\> 65 years old) at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2 (interventions when rSO2 drops below 15% of baseline reading) when compared with current practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and blinded rSO2 measurements).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective coronary artery bypass graft surgery\n* patients at 65 years of age and older\n\nExclusion Criteria:\n\n* diseases of the central nervous system including dementia\n* inadequate knowledge of English\n* a current or past psychiatric illness\n* current use of tranquilizers or antidepressants\n* severe visual, auditory, or motor handicap'}, 'identificationModule': {'nctId': 'NCT01743456', 'briefTitle': 'Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KHC11-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Current practice (BIS and rSO2 blinded)'}, {'type': 'EXPERIMENTAL', 'label': 'Targeted intra-operative depth of anaesthesia', 'interventionNames': ['Other: Targeted intra-operative depth of anaesthesia']}], 'interventions': [{'name': 'Targeted intra-operative depth of anaesthesia', 'type': 'OTHER', 'description': 'The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.', 'armGroupLabels': ['Targeted intra-operative depth of anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'Denmark Hill', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David Green, FRCA, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}