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

Not Applicable

Completed

• Conditions: Post Operative Delirium
• Interventions: 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)

• Registration Number: NCT06614881
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-26
• Primary Completion: 2024-10-15
• Status Verified: 2024-11
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-23
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D-3	Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)	-
Control Group	Normal saline	-
Group D-1	Dexmedetomidine Injection [Precedex]	-
Group D-1	Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)	-
Group D-2	Dexmedetomidine Injection [Precedex]	-
Group D-2	Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)	-
Group D-3	Dexmedetomidine Injection [Precedex]	-

Primary Outcome Measures

Name	Time	Method
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.	3 months

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbyia, Egypt