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

Early Phase 1

Not yet recruiting

• Conditions: Post Operative Cognitive Dysfunction
• Interventions: Drug: Intranasal dexmedetomidine; Drug: intranasal saline group; Drug: intranasal insulin

• Registration Number: NCT06741566
• Lead Sponsor: Minia University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Submitted: 2024-12-24
• Study Start: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-05-10
• Study Completion: 2026-05-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Intranasal dexmedetomidine	-
Control group	intranasal saline group	-
Insulin group	intranasal insulin	-

Primary Outcome Measures

Name	Time	Method
Mini mental state examination	PREOPERATIVE, 1,3,5, days	Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt

Secondary Outcome Measures

Name	Time	Method
Time for extubation	6 hours	hours elapsed from ICU admission until extubation
ICU stay	one week	Days from ICU admission postoperative and discharge to word
serum glucose	1 day before surgery, at time of surgery, at ICU admission, first day, second , third	serum glucose
Serum troponin	preoperative, on admission, 3 days, 5 days	normal level \< 0.12
procedure related complication	3 days	bradycardia, spasm, cough,