Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.
Recruiting now · Early Phase 1
Conditions studied: Post Operative Cognitive Dysfunction
In brief
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
Key facts
- Study ID
- NCT06741566
- Run by
- Minia University
- People needed
- 150
- Starts
- 2024-12-27
- Expected to finish
- 2026-05-15
- Last updated by the study team
- 2026-05-04
Who can join
Age: 60 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
You may not qualify if…
- patient refusal
- combined reperfusion and valve replacement operations.
- Emergency or redo CABG.
- preoperative MMSE score less than 20
- preoperative cardiomyopathy (ejection fraction <40%).
- previous history of cerebrovascular stroke or carotid endarterectomy, dementia, language, hearing or visual impairment precluding accurate neurocognitive assessment.
- history of heparin resistance.
- chronic use of hypnotics (>3 times weekly for >4 weeks), mood stabilizing drugs (lithium, Na valoprate, anticonvulsants) or melatonin.
- pre-operative pacing.
- recent nasal surgery (<3 months), prior maxillofacial trauma with nasal deformity, nasal polyposis or severe allergic rhinitis.
- severe obstructive sleep apnea (apnea hypopnea index >30), central sleep apnea or obesity-hypoventilation syndrome, and planned postoperative non-invasive ventilation.
- Chronic acholic population Alcohol Use Disorders Identification Test (AUDIT) score ≥8 for men or ≥7 for women
Where it is running
- Fayoum university — Al Fayyum, Egypt (enrolling)
Full record on ClinicalTrials.gov
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