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

March 12, 2019 updated by: Jeong-il Choi, Chonnam National University Hospital

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

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollanamdo
      • Hwasun, Jeollanamdo, Korea, Republic of, 501-757
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Principal Investigator:
          • Hyunjung Lee, M.D, master
        • Principal Investigator:
          • Jeongil Choi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 5 minutes up to 120minutes after drug infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 5minutes up to 120minutes after drug infusion
Vital signs
Time Frame: During operation
Check blood pressure, heart rate, oxygen saturation, bispectral index
During operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • an00543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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