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OpenTrials
Completed

NCT Number: NCT05707741

Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

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Key information

About this study

On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA physical status I- II
  • Age from 65to 75 years old,
  • Elective total knee arthroplasty under spinal anaesthesia.

Exclusion criteria

  • Bleeding disorders
  • Allergy to any of the drugs used in the study
  • Renal insufficiency
  • Liver failure-Neurological abnormalities -patients with hearing and visual impairment

Treatment and study plan

dexmetomedine infusion

Drug

50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,

Primary outcomes

  1. cognitive functions

    Time frame: 3 days

    Confusion Assessment Method (CAM)

Secondary outcomes

  1. Post operative pain

    Time frame: 3days

    VAS (0_10)

  2. Sedation

    Time frame: 3days

    Ramsay sedation score

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Feasibility of Different Doses of Dexmetomedine to Prevent Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2023
Registry last updated
Feb 28, 2024

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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