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NCT Number: NCT07443085

Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery

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.

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Key information

Conditions

Delirium - Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Benha university

Banhā, Al Qalyobia, 13511, Egypt

Location status: Recruiting

Location contact

Heshaim Rashid, Prof

CONTACT

[email protected]

101 497 7666 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine (Low dose)

Drug

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).

Dexmedetomidine (High dose)

Drug

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.

Fentanyl

Drug

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 outcomes

  1. Incidence of Postoperative Delirium (POD)

    Time frame: 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 outcomes

  1. Severity of Postoperative Cognitive Dysfunction (POCD)

    Time frame: 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

  2. Postoperative Sedation Level

    Time frame: 24 hours post-surgery

    Evaluation of patient sedation levels using the Ramsey Sedation Score (RSS).

    Unit: Scale Score (1-6)

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Shaboub, MD

CONTACT

[email protected]

01062702236 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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