Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.

Minia University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Post Operative Cognitive Dysfunction

Treatments: Drug: Intranasal dexmedetomidine; Drug: intranasal saline group; Drug: intranasal insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT06741566

640/R

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Treatment:

Drug: intranasal saline group

Insulin group

Active Comparator group

Treatment:

Drug: intranasal insulin

Dexmedetomidine group

Active Comparator group

Treatment:

Drug: Intranasal dexmedetomidine