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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator |
| |
| Insulin group | Active Comparator |
| |
| Dexmedetomidine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal saline group | Drug | 3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mini mental state examination | Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt | PREOPERATIVE, 1,3,5, 7 days , on hospital discharge (up to 3 weeks post operative) AND 3 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Time for extubation | hours elapsed from ICU admission until extubation | 6 hours |
| ICU stay | Days from ICU admission postoperative and discharge to word |
| Measure | Description | Time Frame |
|---|---|---|
| Richards-Campbell Sleep Questionnaire | sleep quality . The counting method was recorded with numbers (0 points to 100 points). The higher the score, the higher the sleep quality star. | DAILY ( EARLY MORNING at 8-9 AM ) THROUHGOUT ICU stay (10 DAYS) |
| Confusion assessment method - ICU |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mina raouf, MD | Contact | 01015752424 | drmina2015@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum university | Recruiting | Al Fayyum | Egypt |
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| intranasal insulin | Drug | 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) |
|
| Intranasal dexmedetomidine | Drug | 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) |
|
| one week |
| serum glucose | serum glucose | 1 day before surgery, at time of surgery, during bypass, 30 minutes after bypass at ICU admission, first day, second , third |
| Serum troponin | normal level < 0.12 | preoperative, on admission, 1, 3 days, 5 days |
| procedure related complication | bradycardia, spasm, cough, | 3 days |
POST PERATIVE DELERIUM. CAM (yes or no) includes four aspects: (1) acute onset and fluctuat- ing course, (2) inattention, (3) incoherent thinking, and (4) altered consciousness; the presence of both (1) and (2), and one of (3) or (4) is diagnostic of POD With a total score of 30, a higher score indicates a lower incidence of neurocognitive dysfunction |
| TWICE DAILY UNTIL ICU DISCHARGE ( 10 DAYS) |
| transcranial doppler | Pulsatality index ( PI) > 0.8 means severe vasospasm | preoperative, 1 day, 3 days, 5, 7 days |
| transcranial doppler | resistive index .. 0.8> severe spasm | preoperative, 1 day, 3 days, 5, 7 days |
| change in MMSE | number and percentage of population with ≥2-point decline in MMSE from preoperative value | 1,3,5,7 days from ICU admission and on hospital discharge (3 WEEKS POST OPERATIVE) AND AT 3 MONTHS POST OPERATIVE |
| Montreal cognitive assessment | preoperative and at 3 months post operative |