Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-03-08 @ 4:34 AM
Study NCT ID:
NCT03089866
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2017-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sedation on Cognitive Performance in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of a single dose of midazolam on cognitive function.', 'timeFrame': 'Baseline to 1hour', 'description': 'Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores before and after sedation'}, {'measure': 'Effect of a single dose of Midazolam on Auditory Activation', 'timeFrame': 'Baseline to 1 hour', 'description': 'Change in Brain activation before and after sedation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central nervous System', 'Memory functions', 'Executive functions', 'Cognitive impairment'], 'conditions': ['Postoperative Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '16803914', 'type': 'BACKGROUND', 'citation': 'Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.'}, {'type': 'BACKGROUND', 'citation': 'Folstein, Marshal F., Susan E. Folstein, and Paul R. McHugh.'}, {'type': 'BACKGROUND', 'citation': 'Wickelgren, Wayne A.'}, {'type': 'BACKGROUND', 'citation': 'Deary, Ian J., and Geoff Der.'}]}, 'descriptionModule': {'briefSummary': "The main goal of this study is to allow the anesthesiologist to make a more informed decision about the anesthetic requirement of a person prior to starting anesthesia. The preliminary data collected in this study will support a larger investigation aimed at gaining a better understanding of anesthetic susceptibility in general and in the elderly population which appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD)\n\nPOCD is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. In rare cases, this disorder may persist for several months after major surgery. POCD is distinct from emergence delirium. It occurs most commonly in older patients and those with pre-existing cognitive impairment. POCD is common in adult patients of all ages at hospital discharge after major non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk for long-term cognitive problems. The body's inflammatory response to surgery likely plays an important role, at least in elderly patients. Investigators also postulate that a relative 'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better judgment on the dose needed for an individual is extremely important.", 'detailedDescription': "Central nervous system (CNS) function is affected by sedation and anesthesia. This is evident from the desired clinical effects of sedative and anesthetic drugs. Recent evidence suggests that disruption CNS function may be prolonged and result in unwanted cognitive effects in predisposed individuals. Investigators know that there is a considerable pharmacokinetic (onset, distribution and elimination) and pharmacokinetic variability of neurotropic drugs even with in persons within a certain age and weight group. What the investigators do not know, is how to predict or quantify an individual's susceptibility to sedation and anesthesia and, more importantly, the potential cognitive susceptibility of an individual's brain to these drugs.\n\nAuditory functional imaging is a well validated task. It can be applied as a short (5 minute) test. Investigators know (preliminary data) that the size of the brain activation area changes after sedation. Investigators now postulate that this change reflects a disruption of neuronal integration in the brain and that this change may be an objective measure of the cognitive effects of sedation for an individual.\n\nAs supportive data for an R-01 grant application the investigators propose to enroll 20 elderly subjects by public advertisement and quantify the effects of sedation with midazolam on auditory activation (auditory fMRI) and cognitive performance (mini Mental State exam and complex reaction time)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants classified by the American Society of Anesthesiologists (ASA) as a Class I or II patient.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a healthy subject\n* 55 years and older\n* Able to follow study instructions.\n\nExclusion Criteria:\n\n* Obesity (BMI \\> 35)\n* Non-English speaking/reading\n* Sleep apnea\n* Moderate to severe bronchial asthma\n* Cardiovascular problems including hypertension\n* History of claustrophobia\n* Presence of a pacemaker,\n* Defibrillator,\n* Any surgically placed metallic object,\n* Presence of bullet or shrapnel in the body,\n* Presence of a non-removable prosthetic,\n* Use of a hearing aid if unable to hear otherwise,\n* Head girth exceeding that of the head coil used in the MRI\n* Extensive metal work on or in teeth\n* Non-removable dentures or bridgework, epilepsy\n* Chronic pain medication use/abuse\n* Excessive tattoos (local skin heating can occur with tattoos containing ferromagnetic particles)\n* History of surgery for which the details are unavailable\n* Allergy to Midazolam\n* History of drug abuse'}, 'identificationModule': {'nctId': 'NCT03089866', 'briefTitle': 'Effect of Sedation on Cognitive Performance in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)', 'orgStudyIdInfo': {'id': 'F141022006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASA Patients I or II', 'description': 'Participants are healthy (BMI \\<35), 55years and older, and have the ability to follow instructions. In this population we will quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).', 'interventionNames': ['Drug: Midazolam (0.02mg/kg)']}], 'interventions': [{'name': 'Midazolam (0.02mg/kg)', 'type': 'DRUG', 'description': 'Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).', 'armGroupLabels': ['ASA Patients I or II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Anesthesiology and Perioperative Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Michael Froelich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology ad Perioperative Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Froelich', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}