Pre-surgery nasal insulin or dexmedetomidine to prevent early thinking and memory problems after elective coronary artery bypass

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

This trial tests whether giving intranasal insulin or dexmedetomidine before elective on-pump coronary artery bypass surgery can prevent early post-operative cognitive dysfunction in people aged 60 and older.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: Minia University (Academic / other)
• Locations: 1 site (Al Fayyum)
• Trial ID: NCT06741566 on ClinicalTrials.gov

What this trial studies

Patients aged 60 and above undergoing elective on-pump coronary artery bypass are assigned to receive one of three intranasal treatments (saline, insulin, or dexmedetomidine) before surgery. The interventions aim to modify pathways linked to post-operative cognitive dysfunction such as neuroinflammation and disrupted sleep-related signaling. Cognitive function is measured before and shortly after surgery to detect early changes in thinking and memory. The study excludes patients with significant baseline cognitive impairment, recent nasal surgery, certain cardiac or respiratory conditions, and other factors that would interfere with accurate neurocognitive assessment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 or older scheduled for elective on-pump coronary artery bypass graft who do not have dementia, recent stroke, severe nasal problems, or other listed exclusions.

Not a fit: Patients with preoperative MMSE under 20, severe cardiomyopathy (EF <40%), prior stroke or dementia, recent nasal surgery, or severe sleep apnea are unlikely to be eligible and may not receive benefit from these interventions.

Why it matters

Potential benefit: If successful, the intervention could reduce early cognitive decline after CABG and improve short-term recovery and quality of life for older patients.

How similar studies have performed: Some small clinical and animal studies suggest intranasal insulin and dexmedetomidine can protect cognitive function, but clinical evidence specifically in cardiac surgery patients is limited and mixed.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* patient refusal
* combined reperfusion and valve replacement operations.
* Emergency or redo CABG.
* preoperative MMSE score less than 20
* preoperative cardiomyopathy (ejection fraction \<40%).
* previous history of cerebrovascular stroke or carotid endarterectomy, dementia, language, hearing or visual impairment precluding accurate neurocognitive assessment.
* history of heparin resistance.
* chronic use of hypnotics (\>3 times weekly for \>4 weeks), mood stabilizing drugs (lithium, Na valoprate, anticonvulsants) or melatonin.
* pre-operative pacing.
* recent nasal surgery (\<3 months), prior maxillofacial trauma with nasal deformity, nasal polyposis or severe allergic rhinitis.
* severe obstructive sleep apnea (apnea hypopnea index \>30), central sleep apnea or obesity-hypoventilation syndrome, and planned postoperative non-invasive ventilation.
* Chronic acholic population Alcohol Use Disorders Identification Test (AUDIT) score ≥8 for men or ≥7 for women

Where this trial is running

Al Fayyum

• Fayoum university — Al Fayyum, Egypt (Recruiting)

Study contacts

• Study coordinator: mina raouf, MD

Conditions Post Operative Cognitive Dysfunction