Alcohol Drinking, Anesthesia, Epidural, Anesthesia, Spinal, Dexmedetomidine, Propofol, Sedation, Conscious
Conditions
Keywords
Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers
Brief summary
1. Adequate sedation with classical sedative agents, propofol 2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol drinkers 3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol drinkers
Detailed description
1. 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. 2. 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. 3. 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.
Interventions
DRUGDexmedetomidine
200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\ 1.0mcg/Kg infusion
DRUGPropofol
25\ 75mcg/kg/min continuous infusion
Sponsors
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paradoxical excitement response | Every 5 minutes up to 120minutes after drug infusion | Paradoxical excitement responses (verbal/movement) 0, none : no excitement response 1. mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining 2. moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint 3. severe : agitation and spontaneous movements with a need to restrain the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OAA/S | Every 5minutes up to 120minutes after drug infusion | Observer''s Assessment of Alertness/Sedation Scale (OAA/S) 1. :Does not respond to mild prodding or shaking 2. :Responds only after mild prodding or shaking 3. :Responds only after name is spoken loudly and/or repeatedly 4. :Lethargic response to name spoken in normal tone 5. :Responds readily to name spoken in normal tone Goal to sedation : 3 |
| Vital signs | During operation | Check blood pressure, heart rate, oxygen saturation, bispectral index |
Countries
South Korea
Outcome results
None listed