Actively Recruiting

Early Phase 1
Age: 60Years - 75Years
All Genders
NCT06741566

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

Led by Minia University · Updated on 2026-05-04

150

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

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.

Who Can Participate

Age: 60Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 60 years or older
  • Both males and females
  • Scheduled for elective on-pump coronary artery bypass graft surgery
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Combined reperfusion and valve replacement surgeries
  • Emergency or repeat coronary artery bypass graft surgery
  • Preoperative Mini Mental State Examination score less than 20
  • Preoperative cardiomyopathy with ejection fraction below 40%
  • History of cerebrovascular stroke, carotid endarterectomy, dementia, or sensory impairments affecting cognitive testing
  • History of heparin resistance
  • Chronic use of hypnotics, mood stabilizing drugs, anticonvulsants, or melatonin
  • Presence of a pre-operative pacemaker
  • Recent nasal surgery within past 3 months, nasal deformity from trauma, nasal polyposis, or severe allergic rhinitis
  • Severe obstructive sleep apnea (apnea hypopnea index over 30), central sleep apnea, obesity-hypoventilation syndrome, or planned postoperative non-invasive ventilation
  • High alcohol use disorder scores (AUDIT score 8 or higher for men, 7 or higher for women)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fayoum university

Al Fayyum, Egypt

Actively Recruiting

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Research Team

M

mina raouf, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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