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

Официальное название

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

Обзор

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

Вмешательства

• Препарат intranasal saline group
  3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)
• Препарат 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)
• Препарат 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)

Первичные конечные точки

• Mini mental state examination [Срок оценки: PREOPERATIVE, 1,3,5, 7 days , on hospital discharge (up to 3 weeks post operative) AND 3 months post operative]

Вторичные конечные точки (5)

• Time for extubation [Срок оценки: 6 hours]
• ICU stay [Срок оценки: one week]
• serum glucose [Срок оценки: 1 day before surgery, at time of surgery, during bypass, 30 minutes after bypass at ICU admission, first day, second , third]
• Serum troponin [Срок оценки: preoperative, on admission, 1, 3 days, 5 days]
• procedure related complication [Срок оценки: 3 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Fayoum university — Al Fayyum

Идентификаторы

NCT: NCT06741566 · 640/R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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