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NCT Number: NCT06741566

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

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

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Key information

Conditions

Post Operative Cognitive Dysfunction

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fayoum university

Al Fayyum, Egypt

Location status: Recruiting

Location contact

Menofia

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Time for extubation

    Time frame: 6 hours

    hours elapsed from ICU admission until extubation

  2. ICU stay

    Time frame: one week

    Days from ICU admission postoperative and discharge to word

  3. 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 glucose

  4. Serum troponin

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

    normal level < 0.12

  5. procedure related complication

    Time frame: 3 days

    bradycardia, spasm, cough,

Other outcomes

  1. Richards-Campbell Sleep Questionnaire

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

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

  2. Confusion assessment method - ICU

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

    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

  3. transcranial doppler

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

    Pulsatality index ( PI) > 0.8 means severe vasospasm

  4. transcranial doppler

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

    resistive index .. 0.8> severe spasm

  5. change in MMSE

    Time frame: 1,3,5,7 days from ICU admission and on hospital discharge (3 WEEKS POST OPERATIVE) AND AT 3 MONTHS POST OPERATIVE

    number and percentage of population with ≥2-point decline in MMSE from preoperative value

  6. Montreal cognitive assessment

    Time frame: preoperative and at 3 months post operative

Study contacts

Contact information is provided by the study sponsor or research team.

mina raouf, MD

CONTACT

[email protected]

01015752424

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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