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

Phase 4

• Conditions: Sedation, Conscious; Anesthesia, Epidural; Dexmedetomidine; Anesthesia, Spinal; Alcohol Drinking; Propofol
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT02197403
• Lead Sponsor: Chonnam National University Hospital

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alcohol drinker & dexmedetomidine	Dexmedetomidine	dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery
Non-alcohol drinker & propofol	Propofol	Propofol (2% fresofol) 25\~75mcg/kg/min continuous infusion
alcohol drinker & propofol	Propofol	Propofol (2% fresofol) 25\~75mcg/kg/min continuous infusion
Non-alcohol drinker & dexmedetomidine	Dexmedetomidine	dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeollanamdo, Korea, Republic of