Post Operative Cognitive DysfunctionEarly Phase 1NCT06741566
Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.
A Early Phase 1 study testing intranasal saline group, intranasal insulin and Intranasal dexmedetomidine in people with Post Operative Cognitive Dysfunction, run by Minia University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Post Operative Cognitive Dysfunction
- What is being tested?
- intranasal saline group, intranasal insulin and Intranasal dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Dec 2024to 15 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- intranasal saline group, intranasal insulin, Intranasal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal saline groupDrug
3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm)
intranasal insulinDrug
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 dexmedetomidineDrug
1.5 mic/kg on 3 ml saline 0.9% at 9 PM at night of surgery and 30 minutes before anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Drug: intranasal saline group |
| Insulin group | Active comparator | Not described Receives: Drug: intranasal insulin |
| Dexmedetomidine group | Active comparator | Not described Receives: Drug: Intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini mental state examination
Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt
Measured: PREOPERATIVE, 1,3,5, 7 days , on hospital discharge
Secondary outcomes (1)
procedure related complication
bradycardia, spasm, cough,
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Dec 2024
- Primary completion14 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741566
- Sponsor's protocol ID
- 640/R
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06741566
- Acronym / sponsor ID
- 640/R
- Conditions
- Post Operative Cognitive Dysfunction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: intranasal saline group |
| Insulin group | Active comparator | Drug: intranasal insulin |
| Dexmedetomidine group | Active comparator | Drug: Intranasal dexmedetomidine |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
Key exclusion criteria (12 listed)
- patient refusal
- combined reperfusion and valve replacement operations.
- Emergency or redo CABG.
- preoperative MMSE score less than 20
- preoperative cardiomyopathy (ejection fraction <40%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intranasal saline group3 ml of saline 0.9 % twice daily for 2 days preoperatively at fixed time ( 9 am and 6 pm) | Drug | Control group |
| intranasal insulin20 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) | Drug | Insulin group |
| Intranasal dexmedetomidine1.5 mic/kg on 3 ml saline 0.9% at 9 PM at night of surgery and 30 minutes before anesthesia induction | Drug | Dexmedetomidine group |
Primary outcome
Mini mental state examination
Time frame: PREOPERATIVE, 1,3,5, 7 days , on hospital discharge
Acute cognitive assessment, score from 0-10 = severe sementia, 10-20 = moderate dementia, 20-25= mild , 25-30= questionably significabt
1 secondary outcome
procedure related complication
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intranasal saline group, intranasal insulin and Intranasal dexmedetomidine in people with Post Operative Cognitive Dysfunction, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini mental state examination (time frame: PREOPERATIVE, 1,3,5, 7 days , on hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.