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

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ClinicalTrials.gov Identifier: NCT02197403
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jeong-il Choi, 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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2013
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Precedex

Active Comparator: alcohol drinker & propofol
Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
Drug: Propofol
25~75mcg/kg/min continuous infusion
Other Name: 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 Name: 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 Name: Fresofol




Primary Outcome Measures :
  1. Paradoxical excitement response [ Time Frame: 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 :
  1. OAA/S [ Time Frame: 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


  2. Vital signs [ Time Frame: During operation ]
    Check blood pressure, heart rate, oxygen saturation, bispectral index



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197403


Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanamdo, Korea, Republic of, 501-757
Contact: Changbeom Park, Master    82-61-379-7598    cnuhpch@naver.com   
Principal Investigator: Hyunjung Lee, M.D, master         
Principal Investigator: Jeongil Choi, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: Hyunjung Lee, MD, Master Chonnam National University Hospital
Study Director: Jeongil Choi, MD, PhD Chonnam National University Hospital
Publications of Results:
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Responsible Party: Jeong-il Choi, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT02197403    
Other Study ID Numbers: an00543
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jeong-il Choi, Chonnam National University Hospital:
Dexmedetomidine
Sedation
Paradoxical excitement response
Alcohol drinkers
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action