[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573076":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Minia University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR",null,[13],"Drug: intranasal saline group",{"label":15,"type":16,"description":11,"interventionNames":17},"Insulin group","ACTIVE_COMPARATOR",[18],"Drug: intranasal insulin",{"label":20,"type":16,"description":11,"interventionNames":21},"Dexmedetomidine group",[22],"Drug: Intranasal dexmedetomidine",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","intranasal saline group","3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"intranasal insulin","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)",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Intranasal dexmedetomidine","1.5 mic\u002Fkg on 3 ml saline 0.9% twice daily for 2 days preoperative via mucosal atomization device at fixed times ( 9 am, 6 pm)",[20],[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"mina raouf, MD","CONTACT","01015752424","drmina2015@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Fayoum university","RECRUITING","Al Fayyum","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],30.8418,29.30995,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":11,"phoneExt":11,"email":11},"Menofia",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mina Maher","Ass professor anesthesia and pain","100573076","early-phase-1-pre-operative-intra-nasal-dexmedetomidine-or-insulin-for-prevention-of-early-post-operative-cognitive-dysfunction-in-patients-undergoing-elective-coronary-artery-bypass-graft-100573076",false,"NCT06741566","Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.","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","Inclusion Criteria:\n\n* Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization\n\nExclusion Criteria:\n\n* patient refusal\n* combined reperfusion and valve replacement operations.\n* Emergency or redo CABG.\n* preoperative MMSE score less than 20\n* preoperative cardiomyopathy (ejection fraction \\\u003C40%).\n* previous history of cerebrovascular stroke or carotid endarterectomy, dementia, language, hearing or visual impairment precluding accurate neurocognitive assessment.\n* history of heparin resistance.\n* chronic use of hypnotics (\\>3 times weekly for \\>4 weeks), mood stabilizing drugs (lithium, Na valoprate, anticonvulsants) or melatonin.\n* pre-operative pacing.\n* recent nasal surgery (\\\u003C3 months), prior maxillofacial trauma with nasal deformity, nasal polyposis or severe allergic rhinitis.\n* severe obstructive sleep apnea (apnea hypopnea index \\>30), central sleep apnea or obesity-hypoventilation syndrome, and planned postoperative non-invasive ventilation.\n* Chronic acholic population Alcohol Use Disorders Identification Test (AUDIT) score ≥8 for men or ≥7 for women","ALL","60 Years","75 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","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",[81],"Post Operative Cognitive Dysfunction","2026-04-28",{"date":84,"type":85},"2026-05-04","ACTUAL",{"date":87,"type":85},"2024-12-27",{"date":89,"type":75},"2026-05-15",{"name":5,"class":6},1]