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

Phase 4UnknownNCT02197403

Chonnam National University Hospital110 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

110

Conditions

Anesthesia, Spinal Sedation, Conscious

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Paradoxical excitement response

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

Time frame: Every 5 minutes up to 120minutes after drug infusion

Secondary Outcomes

OAA/S

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

Time frame: Every 5minutes up to 120minutes after drug infusion

Vital signs

Check blood pressure, heart rate, oxygen saturation, bispectral index

Time frame: During operation