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Recruiting NCT07443085

Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery

Phase II Interventional Delirium - Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine (Low dose), Dexmedetomidine (High dose), Fentanyl.
Who it may be relevant to
Registry conditions: Delirium - Postoperative. Basic parameters: 55 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Incidence of Postoperative Delirium (POD) [Time frame: 48 hours post-surgery]
Secondary outcome measures (2)
  • Severity of Postoperative Cognitive Dysfunction (POCD) [Time frame: 1st and 4th weeks post-surgery]
  • Postoperative Sedation Level [Time frame: 24 hours post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Benha university — Banhā

Identifiers

NCT: NCT07443085 · RC24/2/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗