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

NCT ID: NCT06614881

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-11-01

Brief Summary

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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

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Conditions

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Post Operative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Group D-1

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type 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)

Intervention Type DRUG

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

Group D-2

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type 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)

Intervention Type DRUG

Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h

Group D-3

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type 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)

Intervention Type DRUG

Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h

Interventions

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Dexmedetomidine Injection [Precedex]

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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;

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed B. Abo elkheer

Lecturer of Anesthesiology, Pain, and ICU Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El Gharbyia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR790/7/24

Identifier Type: -

Identifier Source: org_study_id

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