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NCT Number: NCT06614881

Dexmedetomidine Dosage for Postoperative Delirium and Cognitive Function in Elderly TKA Patients

This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.

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Key information

Conditions

Post Operative Delirium 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

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
  • Patients of American Society of Anesthesiologists Classification grades II-III;
  • Patients free of exclusion criteria.

Exclusion criteria

  • Patients of American Society of Anesthesiologists Classification grade >III;
  • Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
  • Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
  • Patients had uncontrolled diabetes mellitus or hypertension;
  • Patients had other causes for limited movement;
  • Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of <7 g%;
  • Patients had local bone disorders that may prevent prosthesis stability;
  • Patients had allergies or contraindications to the study drugs.

Treatment and study plan

Dexmedetomidine Injection [Precedex]

Drug

Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min

Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Drug

Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h

normal saline

Drug

loading dose of saline was injected 10-min before induction of anesthesia.

Primary outcomes

  1. Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2024
Registry last updated
Nov 26, 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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