Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Study Overview
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Brief Summary
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Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

Detailed Description
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On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups

Official Title
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Feasibility of Different Doses of Dexmetomedine to Prevent Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: dexmetomedine infusion
* Drug: Dexmetomedine infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I- II Age from 65to 75 years old, Elective total knee arthroplasty under spinal anaesthesia. Exclusion Criteria: Bleeding disorders Allergy to any of the drugs used in the study Renal insufficiency Liver failure-Neurological abnormalities -patients with hearing and visual impairment

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>normal saline infusion rate 0.4uq/kg /hour | Drug: dexmetomedine infusion<br>* 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,<br>Drug: Dexmetomedine infusion<br>* 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg<br>|
| Active Comparator: Group B<br>dexmetomedine 0.2 µg/kg/hr | Drug: dexmetomedine infusion<br>* 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,<br>Drug: Dexmetomedine infusion<br>* 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg<br>|
| Active Comparator: Group C<br>dexmetomedine 0.4 µg/kg/hr | Drug: dexmetomedine infusion<br>* 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,<br>Drug: Dexmetomedine infusion<br>* 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive functions | Confusion Assessment Method (CAM) | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | VAS (0_10) | 3days | 
| Sedation | Ramsay sedation score | 3days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium , Dexmetomedine