Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04950205
Status:
UNKNOWN
Last Update Posted:
2021-07-06
First Post:
2021-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)', 'timeFrame': 'the 1st day before the surgery；the 1st day after the surgery', 'description': 'Screening scale of cognitive function。The highest score is 30 points, 27 to 30 were divided into normal, less than 27 divided into cognitive dysfunction。But is not sensitive in the early identification of dementia, especially in mild cognitive impairment is poorer.'}, {'measure': 'Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)', 'timeFrame': 'Time Frame: the 1st day before the surgery；the 1st day after the surgery', 'description': 'Screening scale of cognitive function。The highest score is 30 points，Add 1 score, education the following subjects in less than 12 years。Total score less than 26 divided into cognitive dysfunction。Compared with MMSE, more sensitive to mild dementia。'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）', 'description': 'Heart rate per minute'}, {'measure': 'Invasive arterial blood pressure', 'timeFrame': 'Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）', 'description': 'Invasive arterial puncture catheter, continuous arterial pressure monitoring'}, {'measure': 'BIS', 'timeFrame': 'Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）', 'description': 'bispectral index'}, {'measure': 'PETCO2', 'timeFrame': 'Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）', 'description': 'Partial pressure End-Tidal Carbon Dioxide'}, {'measure': 'Cerebral oxygen saturation', 'timeFrame': 'Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）', 'description': 'Cerebral oxygen saturation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction', 'Sevoflurane', 'Carotid Artery Intima Stripped']}, 'descriptionModule': {'briefSummary': 'Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and postoperative radiographic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists（ASA）：II-III\n* Aged between 40 and 80 years\n* Patients scheduled for surgery of Carotid stenosis under general anaesthesia\n\nExclusion Criteria:\n\n* Has a history of mental illness can't cooperate,\n* Serious heart block or cardiac decompensation or severe sinus slow (HR \\< 50 times/min),\n* The abnormal nerve monitoring in operation, MMES preoperative score \\< 20 points,\n* Any rescue unexpected occurred during the operation"}, 'identificationModule': {'nctId': 'NCT04950205', 'briefTitle': 'Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped', 'orgStudyIdInfo': {'id': '2021-0107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane post conditioning group（S1）', 'description': 'propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery', 'interventionNames': ['Drug: Sevoflurane inhalant product']}, {'type': 'NO_INTERVENTION', 'label': 'The control group（P）', 'description': 'propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery without sevoflurane'}], 'interventions': [{'name': 'Sevoflurane inhalant product', 'type': 'DRUG', 'description': 'propofol plus 1% sevoflurane after open Carotid artery until the end of surgery', 'armGroupLabels': ['Sevoflurane post conditioning group（S1）']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Bin, Master', 'role': 'CONTACT', 'email': '381930860@qq.com', 'phone': '+8618806509509'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Bin, Master', 'role': 'CONTACT'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wang Bin, master', 'role': 'CONTACT', 'email': '381930860@qq.com', 'phone': '+8618806509509'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}