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

Tanta University

Status: Completed

Conditions: Post Operative Delirium

Treatments: Drug: Normal saline; Drug: Dexmedetomidine Injection [Precedex]; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Study type: Interventional

Funder types: Other

Identifiers

NCT06614881

36264PR790/7/24

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 4 patient groups, including a placebo group

Control Group

Placebo Comparator group

Treatment:

Drug: Normal saline

Group D-1

Active Comparator group

Treatment:

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

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

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

Drug: Dexmedetomidine Injection [Precedex]

Group D-2

Active Comparator group

Treatment:

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

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

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

Drug: Dexmedetomidine Injection [Precedex]

Group D-3

Active Comparator group

Treatment:

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

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

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

Drug: Dexmedetomidine Injection [Precedex]