Delirium - Postoperative
Conditions
Brief 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.
Interventions
DRUGDexmedetomidine (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).
DRUGDexmedetomidine (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.
DRUGFentanyl
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Delirium (POD) | 48 hours post-surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Postoperative Cognitive Dysfunction (POCD) | 1st and 4th weeks post-surgery | Assessment of cognitive decline using the Mini-Mental State Examination (MMSE) scores compared to baseline. Unit: Score on a scale of 0 to 30 |
| Postoperative Sedation Level | 24 hours post-surgery | Evaluation of patient sedation levels using the Ramsey Sedation Score (RSS). Unit: Scale Score (1-6) |
Countries
Egypt
Outcome results
None listed