Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 1:30 PM
Study NCT ID:
NCT04505059
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2020-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 502}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2020-07-18', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of postoperative complications', 'timeFrame': 'In hospital,up to 10 days, at 1,3 and 12 months after surgery', 'description': 'Postoperative main complications'}, {'measure': 'Rate of mortality', 'timeFrame': 'In hospital,up to 10 days, at 1,3 and 12 months after surgery', 'description': 'All-cause mortality'}, {'measure': "Patient's life quality", 'timeFrame': 'At 1,3 and 12 months after surgery', 'description': 'Quality of life was assessed by SF-36. A self-administered 36-item question- naire covering eight different domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Raw points are transformed into a score from 0 to 100 for each dimension, with 100 reflecting the best possible health-related quality of life.'}], 'primaryOutcomes': [{'measure': 'Rate of postoperative delirium', 'timeFrame': 'Postoperative day 1 to 5', 'description': 'Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period'}], 'secondaryOutcomes': [{'measure': 'Postoperative cognitive function', 'timeFrame': 'In hospital,up to 10 days, at 1,6 and 12 months after surgery', 'description': 'Assessed by MoCA (score range from 0 to 30, higher scores mean a better outcome) or MMSE (score range from 0 to 30, higher scores mean a better outcome)'}, {'measure': 'Ventilation time', 'timeFrame': 'up to 1 month after surgery', 'description': 'Mechanical ventilation time after surgery'}, {'measure': 'Length of stay', 'timeFrame': 'up to 2 months after surgery', 'description': 'Length of hospital and ICU stay'}, {'measure': 'Cost', 'timeFrame': 'up to 2 months after surgery', 'description': 'health care costs of hospital and ICU'}, {'measure': 'PONV', 'timeFrame': 'Postoperative day 1 to 5', 'description': 'To quantify postoperative nausea and vomiting the following score was used:\n\n0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative day 1 to 5, at 1,6 and 12 months after surgery', 'description': 'Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)'}, {'measure': 'IL-6, IL-8, IL-10', 'timeFrame': 'Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery', 'description': 'Inflammatory factor (IL-6, IL-8, IL-10)'}, {'measure': 'TNF-α', 'timeFrame': 'Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery', 'description': 'Inflammatory factor (TNF-α)'}, {'measure': 'IGF-1', 'timeFrame': 'Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery', 'description': 'Blood Biomarker (IGF-1)'}, {'measure': 'CRP', 'timeFrame': 'Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery', 'description': 'Blood Biomarker (CRP)'}, {'measure': 'S-100β protein', 'timeFrame': 'Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery', 'description': 'Blood Biomarker (S-100β protein)'}, {'measure': 'Genotype', 'timeFrame': 'Before surgery', 'description': 'Number of participants with target gene'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative cognitive function', 'Delirium', 'Cardiac Surgical Procedures', 'Precision cardiac anesthesia'], 'conditions': ['Delirium', 'Condition', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, double-blind, randomized clinical trials.', 'detailedDescription': 'Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. Patients will be randomized to two groups in equal proportion. Investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged≥18 years;\n2. ASA:I to III;\n3. Hemodynamic stability, LVEF≥40%;\n4. Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.\n\nExclusion Criteria:\n\n1. Declined to get involved;\n2. Emergency cases, heart transplantation;\n3. Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);\n4. Previous history of drug and alcohol abuse,allergy to general anesthetics;\n5. Preoperative severe dementia, language barrier and mental illness\n6. Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease\n7. Previous history of craniocerebral injury or neurosurgery;\n8. Any other conditions that are considered unsuitable for study participation."}, 'identificationModule': {'nctId': 'NCT04505059', 'briefTitle': 'Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Precision-Delirium-Cognitive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precision cardiac anesthesia', 'description': 'Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation', 'interventionNames': ['Procedure: Precision cardiac anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional cardiac anesthesia', 'description': 'Institutional standard of care.', 'interventionNames': ['Procedure: Conventional cardiac anesthesia']}], 'interventions': [{'name': 'Precision cardiac anesthesia', 'type': 'PROCEDURE', 'description': 'Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.', 'armGroupLabels': ['Precision cardiac anesthesia']}, {'name': 'Conventional cardiac anesthesia', 'type': 'PROCEDURE', 'description': "The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience", 'armGroupLabels': ['Conventional cardiac anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haitao Liu, MD', 'role': 'CONTACT', 'email': 'mzlht@sina.com', 'phone': '+(86)15130119853'}], 'facility': 'The Second Hospital of HeBei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '100037', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuefu Wang, MD', 'role': 'CONTACT', 'email': 'wangyuefu@hotmail.com', 'phone': '+(86) 010-88396509'}, {'name': 'Chunrong Wang, MD', 'role': 'CONTACT', 'email': 'Emancipation258@outlook.com', 'phone': '+(86) 010-88392469'}, {'name': 'Yuefu Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300222', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiange Han, MD', 'role': 'CONTACT', 'email': 'hanjiange@163.com', 'phone': '+(86)022-88185152'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Yuefu Wang, MD', 'role': 'CONTACT', 'email': 'wangyuefu@hotmail.com', 'phone': '+(86)010-88396509'}, {'name': 'Yuchen Gao, MD', 'role': 'CONTACT', 'email': 'gaoyuchen_pumc@hotmail.com', 'phone': '+(86)010-88392469'}], 'overallOfficials': [{'name': 'Yuefu Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC'}, {'name': 'Jiange Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Chest Hospital'}, {'name': 'Haitao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tianjin Chest Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yuefu Wang', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}