Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03914118
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2019-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modafinil to Prevent Postoperative Cognitive Decline
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2013-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rey Auditory Verbal Learning Test (RAVLT) scores', 'timeFrame': '3 months', 'description': "Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms.\n\nThe RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively."}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class I or II\n* Elective surgery\n* Surgery requiring general anesthesia\n\n 4.) Control Group will be-females \\& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.\n\nExclusion Criteria:\n\n* Neurosurgery\n* Cardiac surgery\n* Narcotic or illicit drug abuse\n* Chronic opioid use\n* Chronic use of anxiolytics\n* History of pulmonary disease\n* C02 retention\n* Sleep apnea\n* Obesity'}, 'identificationModule': {'nctId': 'NCT03914118', 'briefTitle': 'Modafinil to Prevent Postoperative Cognitive Decline', 'organization': {'class': 'OTHER', 'fullName': 'The Cooper Health System'}, 'officialTitle': 'An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population', 'orgStudyIdInfo': {'id': '08-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preoperative modafinil + postoperative placebo', 'interventionNames': ['Drug: Preoperative modafinil + postoperative placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preoperative modafinil + postoperative modafinil', 'interventionNames': ['Drug: Preoperative modafinil + postoperative modafinil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Preoperative placebo + postoperative placebo', 'interventionNames': ['Drug: Preoperative placebo + postoperative placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Preoperative modafinil + postoperative placebo', 'type': 'DRUG', 'description': '200 mg modafinil pre-operatively and placebo immediately post-operatively.', 'armGroupLabels': ['Preoperative modafinil + postoperative placebo']}, {'name': 'Preoperative modafinil + postoperative modafinil', 'type': 'DRUG', 'description': '200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.', 'armGroupLabels': ['Preoperative modafinil + postoperative modafinil']}, {'name': 'Preoperative placebo + postoperative placebo', 'type': 'DRUG', 'description': 'Placebo pre-operatively and placebo immediately post-operatively.', 'armGroupLabels': ['Preoperative placebo + postoperative placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cooper Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Regional Anesthesia', 'investigatorFullName': 'Ronak Desai, DO', 'investigatorAffiliation': 'The Cooper Health System'}}}}