Post Operative Cognitive Dysfunction
Conditions
Brief summary
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
Interventions
DRUGintranasal saline group
3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)
DRUGintranasal 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)
DRUGIntranasal dexmedetomidine
1.5 mic/kg on 3 ml saline 0.9% at 9 PM at night of surgery and 30 minutes before anesthesia induction
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini mental state examination | PREOPERATIVE, 1,3,5, 7 days , on hospital discharge | Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | one week | Days from ICU admission postoperative and discharge to word |
| procedure related complication | 3 days | bradycardia, spasm, cough, |
Countries
Egypt
Outcome results
None listed