MedTrace Logo

Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery

NCT07443085 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Delirium - Postoperative

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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2027-07-31
Completion
2027-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443085 on ClinicalTrials.gov