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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
75
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).
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.
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.
Benha university
Banhā, Al Qalyobia, Egypt
RECRUITINGIncidence of Postoperative Delirium (POD)
The percentage of participants diagnosed with delirium within the first 48 hours after surgery. Diagnosis is defined by the Confusion Assessment Method (CAM) algorithm, requiring the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness. Unit of Measure: Percentage of participants
Time frame: 48 hours post-surgery
Severity of Postoperative Cognitive Dysfunction (POCD)
Assessment of cognitive decline using the Mini-Mental State Examination (MMSE) scores compared to baseline. Unit: Score on a scale of 0 to 30
Time frame: 1st and 4th weeks post-surgery
Postoperative Sedation Level
Evaluation of patient sedation levels using the Ramsey Sedation Score (RSS). Unit: Scale Score (1-6)
Time frame: 24 hours post-surgery
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