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

NCT06614881 | Completed

• 1 other identifier: 36264PR790/7/24
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Delirium

Outcome Measures

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.

  3 months

Study Arms (4)

Control Group

PLACEBO COMPARATOR

Drug: Normal saline

Group D-1

ACTIVE COMPARATOR

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

Group D-2

ACTIVE COMPARATOR

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

Group D-3

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine Injection [Precedex] DRUG

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

Group D-1; Group D-2; Group D-3

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

Group D-1

Normal saline DRUG

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

Control Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Pain, and ICU Department

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: July 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 1, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

EG (1)