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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Delirium
• Intervention / Treatment: 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); 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)

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 13511
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Drug: Normal saline; loading dose of saline was injected 10-min before induction of anesthesia.
Active Comparator: Group D-1	Drug: Dexmedetomidine Injection [Precedex]; Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h
Active Comparator: Group D-2	Drug: Dexmedetomidine Injection [Precedex]; Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h
Active Comparator: Group D-3	Drug: Dexmedetomidine Injection [Precedex]; Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 36264PR790/7/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No