Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intranasal saline group, intranasal insulin, Intranasal dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Post Operative Cognitive Dysfunction. Basic parameters: 60 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug intranasal saline group
3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm) - Drug intranasal insulin
20 IU of regular insulin on 3 ml saline 0.9% twice daily for 2 days preoperative via mucosal atomization device at fixed times ( 9 am, 6 pm) - Drug Intranasal dexmedetomidine
1.5 mic/kg on 3 ml saline 0.9% twice daily for 2 days preoperative via mucosal atomization device at fixed times ( 9 am, 6 pm)
Primary outcome measures
- Mini mental state examination [Time frame: PREOPERATIVE, 1,3,5, 7 days , on hospital discharge (up to 3 weeks post operative) AND 3 months post operative]
Secondary outcome measures (5)
- Time for extubation [Time frame: 6 hours]
- ICU stay [Time frame: one week]
- serum glucose [Time frame: 1 day before surgery, at time of surgery, during bypass, 30 minutes after bypass at ICU admission, first day, second , third]
- Serum troponin [Time frame: preoperative, on admission, 1, 3 days, 5 days]
- procedure related complication [Time frame: 3 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Fayoum university — Al Fayyum
Identifiers
NCT: NCT06741566 · 640/R