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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age60-75
SponsorMinia University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patient refusal

combined reperfusion and valve replacement operations.

Emergency or redo CABG.

preoperative MMSE score less than 20

Trial design

Design model

Parallel

Treatments tested in this trial

  • intranasal saline group

    Drug

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

  • intranasal insulin

    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)

  • Intranasal dexmedetomidine

    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)

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Insulin groupActive comparator 1 intervention
Group C: Dexmedetomidine groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mini mental state examination

Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt

Time frame
PREOPERATIVE, 1,3,5, 7 days , on hospital discharge (up to 3 weeks post operative) AND 3 months post operative

Secondary outcomes

1

Time for extubation

hours elapsed from ICU admission until extubation

Time frame
6 hours
2

ICU stay

Days from ICU admission postoperative and discharge to word

Time frame
one week
3

serum glucose

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
4

Serum troponin

normal level \< 0.12

Time frame
preoperative, on admission, 1, 3 days, 5 days

Other outcomes

1

Richards-Campbell Sleep Questionnaire

sleep quality . The counting method was recorded with numbers (0 points to 100 points). The higher the score, the higher the sleep quality star.

Time frame
DAILY ( EARLY MORNING at 8-9 AM ) THROUHGOUT ICU stay (10 DAYS)
2

Confusion assessment method - ICU

POST PERATIVE DELERIUM. CAM (yes or no) includes four aspects: (1) acute onset and fluctuat- ing course, (2) inattention, (3) incoherent thinking, and (4) altered consciousness; the presence of both (1) and (2), and one of (3) or (4) is diagnostic of POD With a total score of 30, a higher score indicates a lower incidence of neurocognitive dysfunction

Time frame
TWICE DAILY UNTIL ICU DISCHARGE ( 10 DAYS)
3

transcranial doppler

Pulsatality index ( PI) \> 0.8 means severe vasospasm

Time frame
preoperative, 1 day, 3 days, 5, 7 days
4

transcranial doppler

resistive index .. 0.8\> severe spasm

Time frame
preoperative, 1 day, 3 days, 5, 7 days

Sponsors and contacts

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