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

Chonnam National University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02197403

an00543

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 4 patient groups

alcohol drinker & dexmedetomidine

Experimental group

Description:

dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery

Treatment:

Drug: Dexmedetomidine

alcohol drinker & propofol

Active Comparator group

Description:

Propofol (2% fresofol) 25\~75mcg/kg/min continuous infusion

Treatment:

Drug: Propofol

Non-alcohol drinker & dexmedetomidine

Active Comparator group

Description:

dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery

Treatment:

Drug: Dexmedetomidine

Non-alcohol drinker & propofol

Active Comparator group

Description:

Propofol (2% fresofol) 25\~75mcg/kg/min continuous infusion

Treatment:

Drug: Propofol