Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-22 @ 4:11 AM
Study NCT ID:
NCT04168294
Status:
TERMINATED
Last Update Posted:
2019-11-19
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Sedation for Endoscopy on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D004724', 'term': 'Endoscopy'}], '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': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The number of subjects did not meet the requirements', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-16', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2019-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NCT-A test outcome measure', 'timeFrame': '30 minutes', 'description': 'the score of NCT-A test for each patient is not less than that in the baseline.'}, {'measure': 'DST test outcome measure', 'timeFrame': '30 minutes', 'description': 'the score of DST for each patient is not less than that in the baseline.'}, {'measure': 'number cancellation test outcome measure', 'timeFrame': '30 minutes', 'description': 'the score of number cancellation test for each patient is not less than that in the baseline.'}], 'secondaryOutcomes': [{'measure': 'heart rate outcome measure', 'timeFrame': '5 minutes', 'description': 'heart rate less than 50 time per minute'}, {'measure': 'SpO2 outcome measure', 'timeFrame': '5 minutes', 'description': 'SpO2 less than 90%'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Esophagogastroduodenoscopy', 'Deep Sedation', 'Cognition Disorders', 'Patient Discharge', 'Automobile Driving'], 'conditions': ['Esophagogastroduodenoscopy', 'Deep Sedation', 'Cognition Disorders']}, 'descriptionModule': {'briefSummary': 'It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.', 'detailedDescription': 'One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The scores of MMSE are more than 26.\n2. The AHA grade I and II.\n\nExclusion Criteria:\n\n1. The AHA grade III, IV or V.\n2. binge drinking.\n3. Take sedatives, sleeping agents and some drug which may affect the study in a month.\n4. Psychiatric disorders.\n5. The dysfunction of heart, lung, liver and kidney.'}, 'identificationModule': {'nctId': 'NCT04168294', 'briefTitle': 'The Influence of Sedation for Endoscopy on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Influence of Sedation for Endoscopy on Cognitive Function', 'orgStudyIdInfo': {'id': 'rjyyxhk2017001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sedation group', 'description': 'Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus', 'interventionNames': ['Drug: Propofol', 'Device: endoscopy']}, {'label': 'control group', 'description': 'patients undergo conventional EGD', 'interventionNames': ['Device: endoscopy']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'patients in sedation group will be intravenous injected propofol in bolus', 'armGroupLabels': ['sedation group']}, {'name': 'endoscopy', 'type': 'DEVICE', 'otherNames': ['Olympus Lucera Elite 290 system'], 'description': 'endoscopy system', 'armGroupLabels': ['control group', 'sedation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wei-Ping Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Renji Hospital, School of Medicine,Shanghai Jiao Tong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University', 'investigatorFullName': 'Zhizheng Ge', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}