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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02197403

Collaborator

(none)

110

Enrollment

Location

Arms

65.9

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adequate sedation with classical sedative agents, propofol
Sedation with propofol may induce paradoxical excitement response in heavy alcohol drinkers
Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol drinkers

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Spinal Sedation, Conscious Dexmedetomidine Alcohol Drinking Anesthesia, Epidural Propofol	Drug: Dexmedetomidine Drug: Propofol	Phase 4

Detailed Description

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.
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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

May 31, 2019

Anticipated Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alcohol drinker & dexmedetomidine dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery	Drug: Dexmedetomidine 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion Other Names: Precedex
Active Comparator: alcohol drinker & propofol Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion	Drug: Propofol 25~75mcg/kg/min continuous infusion Other Names: Fresofol
Active Comparator: Non-alcohol drinker & dexmedetomidine dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery	Drug: Dexmedetomidine 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion Other Names: Precedex
Active Comparator: Non-alcohol drinker & propofol Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion	Drug: Propofol 25~75mcg/kg/min continuous infusion Other Names: Fresofol

Outcome Measures

Primary Outcome Measures

Paradoxical excitement response [Every 5 minutes up to 120minutes after drug infusion]
Paradoxical excitement responses (verbal/movement) 0, none : no excitement response mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint severe : agitation and spontaneous movements with a need to restrain the patient

Secondary Outcome Measures

OAA/S [Every 5minutes up to 120minutes after drug infusion]
Observer''s Assessment of Alertness/Sedation Scale (OAA/S) :Does not respond to mild prodding or shaking :Responds only after mild prodding or shaking :Responds only after name is spoken loudly and/or repeatedly :Lethargic response to name spoken in normal tone :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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonnam National University Hwasun Hospital	Hwasun	Jeollanamdo	Korea, Republic of	501-757

Sponsors and Collaborators

Chonnam National University Hospital

Investigators

Principal Investigator: Hyunjung Lee, MD, Master, Chonnam National University Hospital
Study Director: Jeongil Choi, MD, PhD, Chonnam National University Hospital