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

NCT ID: NCT06741566

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-27

Study Completion Date

2026-05-11

Brief Summary

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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

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Conditions

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Post Operative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Group Type PLACEBO_COMPARATOR

intranasal saline group

Intervention Type DRUG

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

Insulin group

Group Type ACTIVE_COMPARATOR

intranasal insulin

Intervention Type DRUG

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)

Dexmedetomidine group

Group Type ACTIVE_COMPARATOR

Intranasal dexmedetomidine

Intervention Type DRUG

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)

Interventions

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intranasal saline group

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

Intervention Type 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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Ass professor anesthesia and pain

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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640/R

Identifier Type: -

Identifier Source: org_study_id