Clinical trial NCT06741566: Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Operative Cognitive Dysfunction
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization

Exclusion Criteria:

* Combined reperfusion and valve replacement operations.
* Emergency or redo CABG surgery.
* Preoperative MMSE less than 20
* Diabetic or chronic alcoholic population.
* Pre-operative cardiomyopathy (Ejection fraction less than 40%).
* Previous cerebro-vascular stroke or carotid endarterectomy.
* Previous history of carotid endarterectomy.
* History of heparin resistance.
* Preoperative history of dementia, language impairment, severe visual and hearing impairment, any psychiatric disorder.
* Chronic use of hynotics, mode stabilizing drugs or melatonin.
* Reoperation for emergency surgical issues during hospital stay.
* Patient refusal
* Loss to follow up ( patient dyscompliance, mortality)
* population with failed weaning from CPB and the use ventricular assisted device ( intraaortic ballon- impella)
* Pre or post operative pacing.

Primary outcomes:
measure: Mini mental state examination
timeFrame: PREOPERATIVE, 1,3,5, days
Secondary outcomes:
measure: Time for extubation
timeFrame: 6 hours
measure: ICU stay
timeFrame: one week
measure: serum glucose
timeFrame: 1 day before surgery, at time of surgery, at ICU admission, first day, second , third
measure: Serum troponin
timeFrame: preoperative, on admission, 3 days, 5 days
measure: procedure related complication
timeFrame: 3 days
Other outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: preoperative assessment, score from 0-21. 0-10= very good sleep, 10-15= mild impairment, 15-21= significant sleep disturbance with higher score indicates poor sleep quality
measure: Richards-Campbell Sleep Questionnaire
timeFrame: preoperative, 1,3, 5, days postoperative
measure: Confusion assessment method - ICU
timeFrame: PREOPERTIVE, 1,3,5, DAYS
measure: Epworth sleepiness scale
timeFrame: preoperative, 1,3,5 days after
measure: transcranial doppler
timeFrame: preoperative, 1 day, 3 days, 5 days
measure: transcranial doppler
timeFrame: preoperative, 1 day, 3 days, 5 days
Locations:
Study officials:
References: