Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 3:03 AM
Study NCT ID:
NCT02197403
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
Sponsor:
Chonnam National University Hospital
Organization:
Study Overview
Official Title:
Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEX
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: