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RECRUITING
NCT07443085
PHASE2

Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery

Sponsor: Benha University

View on ClinicalTrials.gov

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.

Official title: Dose-Effect Relationship of Dexmedetomidine on Delirium and Cognitive Function After Lower Limb Orthopedic Surgeries for Elderly Patients

Key Details

Gender

All

Age Range

55 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-02-26

Completion Date

2027-10

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine (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).

DRUG

Dexmedetomidine (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.

DRUG

Fentanyl

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.

Locations (1)

Benha university

Banhā, Al Qalyobia, Egypt