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Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery

ConditionDelirium - Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-70
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elderly surgical patients.

ASA physical status grade II-III.

Planned major lower limb orthopedic surgery.

Disqualifiers

pre-existing dementia or drug allergies

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: DEX Group 1 (Low Dose)Active comparator 1 intervention
Group B: DEX Group 1 (High Dose)Active comparator 1 intervention
Group C: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Delirium (POD)

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

Time frame
48 hours post-surgery

Secondary outcomes

1

Severity of Postoperative Cognitive Dysfunction (POCD)

Assessment of cognitive decline using the Mini-Mental State Examination (MMSE) scores compared to baseline. Unit: Score on a scale of 0 to 30

Time frame
1st and 4th weeks post-surgery
2

Postoperative Sedation Level

Evaluation of patient sedation levels using the Ramsey Sedation Score (RSS). Unit: Scale Score (1-6)

Time frame
24 hours post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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