Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker

Study Overview
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Brief Summary
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Adequate sedation with classical sedative agents, propofol Sedation with propofol may induce paradoxical excitement response in heavy alcohol drinkers Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol drinkers

Detailed Description
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Adequate sedation during surgery provide anxiolysis and comfort to patient. Insufficient sedation can't provide comfort to patient during surgery, otherwise excessive sedation can cause variable complications like respiratory depression or delayed awakening. Dexmedetomidine is a centrally acting α2 receptor agonist that is increasingly being used as a sedative for MAC and intensive care with mechanical ventilated patients because of its analgesic properties, cooperative sedation, and lack of respiratory depression. Because of the different site of action between dexmedetomidine and propofol, we assumed that paradoxical excitement responses which appeared in heavy alcohol drinkers in midazolam or propofol-induced sedation might be less observed in dexmedetomidine-induced sedation.

Official Title
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Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers

Conditions
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Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine, Alcohol Drinking, Anesthesia, Epidural, Propofol

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia Exclusion Criteria: History of taking anxiolytics, hypnotics, antiepileptic drugs Abnormal liver function test (eg: Liver cirrhosis, elevated liver enzymes) History of allergic reaction with dexmedetomidine or propofol Contraindication with regional anesthesia American society of anesthesiologist Physical status III or IV

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alcohol drinker & dexmedetomidine<br>dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1 1.0mcg/Kg infusion during surgery | Drug: Dexmedetomidine<br>* 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1 1.0mcg/Kg infusion<br>* Other names: Precedex;|
| Active Comparator: alcohol drinker & propofol<br>Propofol (2% fresofol) 25 75mcg/kg/min continuous infusion | Drug: Propofol<br>* 25 75mcg/kg/min continuous infusion<br>* Other names: Fresofol;|
| Active Comparator: Non-alcohol drinker & dexmedetomidine<br>dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1 1.0mcg/Kg infusion during surgery | Drug: Dexmedetomidine<br>* 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1 1.0mcg/Kg infusion<br>* Other names: Precedex;|
| Active Comparator: Non-alcohol drinker & propofol<br>Propofol (2% fresofol) 25 75mcg/kg/min continuous infusion | Drug: Propofol<br>* 25 75mcg/kg/min continuous infusion<br>* Other names: Fresofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paradoxical excitement response | Paradoxical excitement responses (verbal/movement) 0, none : no excitement response mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint severe : agitation and spontaneous movements with a need to restrain the patient | Every 5 minutes up to 120minutes after drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAA/S | Observer''s Assessment of Alertness/Sedation Scale (OAA/S) :Does not respond to mild prodding or shaking :Responds only after mild prodding or shaking :Responds only after name is spoken loudly and/or repeatedly :Lethargic response to name spoken in normal tone :Responds readily to name spoken in normal tone Goal to sedation : 3 | Every 5minutes up to 120minutes after drug infusion | 
| Vital signs | Check blood pressure, heart rate, oxygen saturation, bispectral index | During operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers