Dexmedetomidine dosing to reduce delirium after major lower-limb orthopedic surgery in older adults
Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients
This trial tests whether different doses of dexmedetomidine given during general anesthesia can reduce postoperative delirium and cognitive problems in older adults having major lower-limb orthopedic surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Al Qalyobia) |
| Trial ID | NCT07443085 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study compares low-dose and high-dose dexmedetomidine with a fentanyl control in elderly patients undergoing major lower limb orthopedic surgery under general anesthesia. Eligible participants (elderly, ASA II–III) without pre-existing dementia or drug allergies receive one of the study infusions during surgery and are followed for postoperative delirium and cognitive function. The primary focus is the dose–response relationship between dexmedetomidine and the incidence and severity of postoperative delirium and postoperative cognitive dysfunction, with safety and adverse events monitored as secondary outcomes. Findings will be used to identify an optimal dosing strategy for cognitive protection in this surgical population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients (ASA II–III) scheduled for major lower-limb orthopedic surgery under general anesthesia who do not have pre-existing dementia or allergies to the study drugs.
Not a fit: Patients with pre-existing dementia, known allergy to dexmedetomidine or fentanyl, or those not undergoing major lower-limb orthopedic surgery are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the trial could lower the rate and severity of postoperative delirium and cognitive problems, improving recovery and functional outcomes for older surgical patients.
How similar studies have performed: Previous studies have suggested dexmedetomidine can reduce delirium risk in some surgical settings, but the optimal dosing for geriatric orthopedic patients remains uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elderly surgical patients. * ASA physical status grade II-III. * Planned major lower limb orthopedic surgery. Exclusion Criteria: * pre-existing dementia or drug allergies
Where this trial is running
Banhā, Al Qalyobia
- Benha university — Banhā, Al Qalyobia, Egypt (Recruiting)
Study contacts
- Study coordinator: Islam Shaboub, MD
- Email: basmasalem758@gmail.com
- Phone: 01062702236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.