Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-29 @ 3:51 AM
Study NCT ID:
NCT06741566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-05-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-12-14', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'preoperative assessment, score from 0-21. 0-10= very good sleep, 10-15= mild impairment, 15-21= significant sleep disturbance with higher score indicates poor sleep quality', 'description': 'Patient sleep status in the last month'}, {'measure': 'Richards-Campbell Sleep Questionnaire', 'timeFrame': 'preoperative, 1,3, 5, days postoperative', 'description': 'sleep quality . The counting method was recorded with numbers (0 points to 100 points). The higher the score, the higher the sleep quality star.'}, {'measure': 'Confusion assessment method - ICU', 'timeFrame': 'PREOPERTIVE, 1,3,5, DAYS', 'description': 'POST PERATIVE DELERIUM. CAM includes four aspects: (1) acute onset and fluctuat- ing course, (2) inattention, (3) incoherent thinking, and (4) altered consciousness; the presence of both\n\n(1) and (2), and one of (3) or (4) is diagnostic of POD\n\nWith a total score of 30, a higher score indicates a lower incidence of neurocognitive dysfunction'}, {'measure': 'Epworth sleepiness scale', 'timeFrame': 'preoperative, 1,3,5 days after', 'description': 'patient awarness of sleepiness. Eight questions each score from 0 to 3. 0-10= normal range.\n\n11-14=mild sleepiness.. 15-17= moderate sleepiness.... \\> 18= severe sleepiness'}, {'measure': 'transcranial doppler', 'timeFrame': 'preoperative, 1 day, 3 days, 5 days', 'description': 'Pulsatality index ( PI) \\> 0.8 means severe vasospasm'}, {'measure': 'transcranial doppler', 'timeFrame': 'preoperative, 1 day, 3 days, 5 days', 'description': 'resistive index .. 0.8\\> severe spasm'}], 'primaryOutcomes': [{'measure': 'Mini mental state examination', 'timeFrame': 'PREOPERATIVE, 1,3,5, days', 'description': 'Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt'}], 'secondaryOutcomes': [{'measure': 'Time for extubation', 'timeFrame': '6 hours', 'description': 'hours elapsed from ICU admission until extubation'}, {'measure': 'ICU stay', 'timeFrame': 'one week', 'description': 'Days from ICU admission postoperative and discharge to word'}, {'measure': 'serum glucose', 'timeFrame': '1 day before surgery, at time of surgery, at ICU admission, first day, second , third', 'description': 'serum glucose'}, {'measure': 'Serum troponin', 'timeFrame': 'preoperative, on admission, 3 days, 5 days', 'description': 'normal level \\< 0.12'}, {'measure': 'procedure related complication', 'timeFrame': '3 days', 'description': 'bradycardia, spasm, cough,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'On pump coronary revascularization is a very common leading cause for post-operative cognitive dysfunction regarding patient age grouping and diffuse systemic inflammatory response induced by bypass machine . Many factors are incriminated as pre-operative sleep disturbance, previous history of neurocognitive dysfunction. The accumulating evidence refers to an incidence between 20-40% with majority among geriatric population. The primary pathology is still elusive and many trials are under evaluation. Neuro-inflammation, hypo perfusion, fat emboli and reperfusion injury are among the most postulative aetiologias. The corner stone in the pathology of postoperative cognitive dysfunction is abnormal sleep rhythm. Intra-nasal insulin can provide neuroprotection via providing insulin growth factor and obtund neuronal apoptosis , while dexmedetomidine can antagonize neural-degeneration via regulation of systematic inflammatory cytokines including interleukin 1β, tumor necrosis factor-α, and NF-κB, inhibiting the expressions of Toll-like receptor , and through α2 adrenoceptor-mediated anti-inflammatory pathways'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization\n\nExclusion Criteria:\n\n* Combined reperfusion and valve replacement operations.\n* Emergency or redo CABG surgery.\n* Preoperative MMSE less than 20\n* Diabetic or chronic alcoholic population.\n* Pre-operative cardiomyopathy (Ejection fraction less than 40%).\n* Previous cerebro-vascular stroke or carotid endarterectomy.\n* Previous history of carotid endarterectomy.\n* History of heparin resistance.\n* Preoperative history of dementia, language impairment, severe visual and hearing impairment, any psychiatric disorder.\n* Chronic use of hynotics, mode stabilizing drugs or melatonin.\n* Reoperation for emergency surgical issues during hospital stay.\n* Patient refusal\n* Loss to follow up ( patient dyscompliance, mortality)\n* population with failed weaning from CPB and the use ventricular assisted device ( intraaortic ballon- impella)\n* Pre or post operative pacing.'}, 'identificationModule': {'nctId': 'NCT06741566', 'briefTitle': 'Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft. A Comparative Randomized Bi-centric Study', 'orgStudyIdInfo': {'id': '640/R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Drug: intranasal saline group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin group', 'interventionNames': ['Drug: intranasal insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group', 'interventionNames': ['Drug: Intranasal dexmedetomidine']}], 'interventions': [{'name': 'intranasal saline group', 'type': 'DRUG', 'description': '3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)', 'armGroupLabels': ['Control group']}, {'name': 'intranasal insulin', 'type': 'DRUG', 'description': '20 IU of regular insulin on 3 ml saline 0.9% twice daily for 2 days preoperative via mucosal atomization device at fixed times ( 9 am, 6 pm)', 'armGroupLabels': ['Insulin group']}, {'name': 'Intranasal dexmedetomidine', 'type': 'DRUG', 'description': '1.5 mic/kg on 3 ml saline 0.9% twice daily for 2 days preoperative via mucosal atomization device at fixed times ( 9 am, 6 pm)', 'armGroupLabels': ['Dexmedetomidine group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass professor anesthesia and pain', 'investigatorFullName': 'Mina Maher', 'investigatorAffiliation': 'Minia University'}}}}