NCT02197403

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion
DRUG	Propofol	25\~75mcg/kg/min continuous infusion

Timeline

• Start date: 2013-12-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2014-07-22
• Last updated: 2019-03-14

Locations

1 site across 1 country: South Korea