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Prevention study for Post Operative Cognitive Dysfunction
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.
ClinicalTrials.gov ID: NCT06741566
What this study is testing
What is intranasal saline group?
intranasal saline group is an investigational medicine, given as an once-daily, being studied as a potential treatment for post operative cognitive dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 75
You may be able to join if
- Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
You likely can't join 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...
See the full eligibility criteria
- Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Al Fayyum, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Fayyum, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.