Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study evaluates the dose-response relationship of Dexmedetomidine (DEX) in reducing the incidence and severity of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in elderly patients. The study compares different doses of DEX against a fentanyl control group in patients undergoing major lower limb orthopedic surgery under general anesthesia to determine the optimal dosage for cognitive protection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 70
Healthy Volunteers: f
View:
• Elderly surgical patients.
• ASA physical status grade II-III.
• Planned major lower limb orthopedic surgery.
Locations
Other Locations
Egypt
Benha university
RECRUITING
Banhā
Contact Information
Primary
Islam Shaboub, MD
basmasalem758@gmail.com
01062702236
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2027-10
Participants
Target number of participants: 75
Treatments
Active_comparator: DEX Group 1 (Low Dose)
Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD).
Active_comparator: DEX Group 1 (High Dose)
Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose.
Active_comparator: Control Group
Patients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline.
Related Therapeutic Areas
Sponsors
Leads: Benha University