About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
Disqualifiers
patient refusal
combined reperfusion and valve replacement operations.
Emergency or redo CABG.
preoperative MMSE score less than 20
Trial design
Parallel
Treatments tested in this trial
intranasal saline group
Drug3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)
intranasal insulin
Drug20 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
Drug1.5 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)
Treatment groups
Trial outcomes
Primary outcomes
Mini mental state examination
Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt
Secondary outcomes
Time for extubation
hours elapsed from ICU admission until extubation
ICU stay
Days from ICU admission postoperative and discharge to word
serum glucose
serum glucose
Serum troponin
normal level \< 0.12
Other outcomes
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.
Confusion assessment method - ICU
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
transcranial doppler
Pulsatality index ( PI) \> 0.8 means severe vasospasm
transcranial doppler
resistive index .. 0.8\> severe spasm
Sponsors and contacts
Click on the lead sponsor to view all of their trials.