Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT03527134
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Amantadine on Postoperative Cognitive Dysfunction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000547', 'term': 'Amantadine'}], 'ancestors': [{'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: one with amantadine treatment and the other with amantadine treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)', 'timeFrame': 'At 7 days after the surgery', 'description': "The existence of POCD will be determined by Visual Verbal Learning Test based on the Rey's Auditory Recall of words, Concept Shifting Test, Stroop Color Word Interference Test and Letter-Digit Coding based on the Symbol Digit Substitution Test"}], 'secondaryOutcomes': [{'measure': 'Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)', 'timeFrame': 'At 3 months after the surgery', 'description': "The existence of POCD will be determined by Visual Verbal Learning Test based on the Rey's Auditory Recall of words, Concept Shifting Test, Stroop Color Word Interference Test and Letter-Digit Coding based on the Symbol Digit Substitution Test"}, {'measure': 'Time for bowel function return after surgery', 'timeFrame': 'up to 2 weeks after the surgery'}, {'measure': 'Degree of increase of stress hormone', 'timeFrame': 'Up to 5 days after the surgery', 'description': 'Adrenocorticotropic Hormone'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 3 months after the surgery'}, {'measure': 'Degree of change in growth factor', 'timeFrame': 'Up to 5 days after the surgery', 'description': 'Brain-derived neurotrophic factor and glial cell derived neurotrophic factor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly patients with major abdominal surgery.', 'detailedDescription': 'Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) no-treatment group, and 2) amantadine-treated group. Each group will have 150 patients. In addition, investigators will need 90 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old.\n2. the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.\n3. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.\n\nExclusion Criteria:\n\n1. Patients are not expected to be alive for longer than 3 months.\n2. Mini-mental State Examination (MMSE) \\[18\\] score ≤ 23.\n3. history of dementia, psychiatric illness or any diseases of central nervous system.\n4. current use of sedatives or antidepressant.\n5. alcoholism and drug dependence.\n6. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).\n7. difficult to follow up or patients with poor compliance.\n8. uncontrolled hypertension (\\> 180/100 mmHg)'}, 'identificationModule': {'nctId': 'NCT03527134', 'briefTitle': 'Effects of Amantadine on Postoperative Cognitive Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery', 'orgStudyIdInfo': {'id': '2017-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amantadine treatment', 'description': 'To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.', 'interventionNames': ['Drug: Amantadine']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment', 'description': 'Patients will not receive any treatment.'}], 'interventions': [{'name': 'Amantadine', 'type': 'DRUG', 'description': 'patients will receive amantadine 100 mg by month 2 h before the induction of general anesthesia and then 100 mg each time, three times per day for 5 days.', 'armGroupLabels': ['Amantadine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yujuan Li, MD, Ph.D.', 'role': 'CONTACT', 'email': 'Yujuan_04@hotmail.com', 'phone': '15918734156'}, {'name': 'Yujuan Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-Sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yujuan Li, MD', 'role': 'CONTACT', 'email': 'yujuan_04@hotmail.com', 'phone': '15918734156'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhiyi Zuo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhiyi Zuo', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}