Actively Recruiting
Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients
Led by Benha University · Updated on 2026-03-02
75
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how different doses of Dexmedetomidine (DEX) affect the occurrence and severity of postoperative delirium (POD) and cognitive problems after surgery in elderly patients. The study focuses on those undergoing major lower limb orthopedic surgery under general anesthesia and compares DEX doses to a fentanyl control group to find the best dose for protecting brain function after surgery. Participants are randomly assigned to receive either a low dose or a high dose of Dexmedetomidine through an intravenous infusion during surgery, or standard opioid-based general anesthesia with fentanyl without Dexmedetomidine. The study evaluates whether higher doses of DEX reduce delirium and cognitive decline more than the lower dose or fentanyl alone. During the study, participants are monitored for delirium within 48 hours after surgery, sedation levels within 24 hours, and cognitive function at the first and fourth weeks after surgery. The study lasts through these assessment periods to understand how DEX dosing influences postoperative brain health and recovery in elderly orthopedic patients.
CONDITIONS
Brief Title
Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elderly surgical patients
- ASA physical status grade II-III
- Planned major lower limb orthopedic surgery
You will not qualify if you...
- Pre-existing dementia
- Drug allergies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery
Participants receive intravenous infusion of Dexmedetomidine (low or high dose) or standard opioid-based general anesthesia with fentanyl during major lower limb orthopedic surgery.
1 visit (in-person)
Duration - 4 weeks post-surgery
Participants are monitored for postoperative delirium and cognitive function after surgery.
Visits at 24 hours, 48 hours, 1 week, and 4 weeks post-surgery
Trial Site Locations
Total: 1 location
1
Benha university
Banhā, Al Qalyobia, Egypt, 13511
Actively Recruiting
Research Team
I
Islam Shaboub, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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