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

NCT06741566 | Recruiting Early Phase 1

• 1 other identifier: 640/R
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Cognitive Dysfunction

Outcome Measures

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

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

Secondary Outcomes (5)

• Time for extubation

  6 hours

• ICU stay

  one week

• serum glucose

  1 day before surgery, at time of surgery, during bypass, 30 minutes after bypass at ICU admission, first day, second , third

• Serum troponin

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

• procedure related complication

  3 days

Other Outcomes (6)

• Richards-Campbell Sleep Questionnaire

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

• Confusion assessment method - ICU

  TWICE DAILY UNTIL ICU DISCHARGE ( 10 DAYS)

• transcranial doppler

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

Study Arms (3)

Control group

PLACEBO COMPARATOR

Drug: intranasal saline group

Insulin group

ACTIVE COMPARATOR

Drug: intranasal insulin

Dexmedetomidine group

ACTIVE COMPARATOR

Drug: Intranasal dexmedetomidine

Interventions

intranasal saline group DRUG

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

Control group

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)

Insulin group

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)

Dexmedetomidine group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Fayoum university

Al Fayyum, Egypt

RECRUITING

Central Study Contacts

mina raouf, MD

CONTACT

01015752424; drmina2015@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass professor anesthesia and pain

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 19, 2024
• Study Start: December 27, 2024
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

EG (1)