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

Primary Purpose

Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, Spinal focused on measuring Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

alcohol drinker & dexmedetomidine

alcohol drinker & propofol

Non-alcohol drinker & dexmedetomidine

Non-alcohol drinker & propofol

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Paradoxical excitement response
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
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
Check blood pressure, heart rate, oxygen saturation, bispectral index

Full Information

First Posted
July 21, 2014
Last Updated
March 12, 2019
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02197403
Brief Title
Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
Acronym
DEX
Official Title
Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine, Alcohol Drinking, Anesthesia, Epidural, Propofol
Keywords
Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alcohol drinker & dexmedetomidine
Arm Type
Experimental
Arm Description
dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
Arm Title
alcohol drinker & propofol
Arm Type
Active Comparator
Arm Description
Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
Arm Title
Non-alcohol drinker & dexmedetomidine
Arm Type
Active Comparator
Arm Description
dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
Arm Title
Non-alcohol drinker & propofol
Arm Type
Active Comparator
Arm Description
Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Fresofol
Intervention Description
25~75mcg/kg/min continuous infusion
Primary Outcome Measure Information:
Title
Paradoxical excitement response
Description
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
Time Frame
Every 5 minutes up to 120minutes after drug infusion
Secondary Outcome Measure Information:
Title
OAA/S
Description
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
Time Frame
Every 5minutes up to 120minutes after drug infusion
Title
Vital signs
Description
Check blood pressure, heart rate, oxygen saturation, bispectral index
Time Frame
During operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunjung Lee, MD, Master
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeongil Choi, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanamdo
ZIP/Postal Code
501-757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changbeom Park, Master
Phone
82-61-379-7598
Email
cnuhpch@naver.com
First Name & Middle Initial & Last Name & Degree
Hyunjung Lee, M.D, master
First Name & Middle Initial & Last Name & Degree
Jeongil Choi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21903640
Citation
Jeong S, Lee HG, Kim WM, Jeong CW, Lee SH, Yoon MH, Choi JI. Increase of paradoxical excitement response during propofol-induced sedation in hazardous and harmful alcohol drinkers. Br J Anaesth. 2011 Dec;107(6):930-3. doi: 10.1093/bja/aer275. Epub 2011 Sep 7.
Results Reference
result
PubMed Identifier
23748199
Citation
Adams R, Brown GT, Davidson M, Fisher E, Mathisen J, Thomson G, Webster NR. Efficacy of dexmedetomidine compared with midazolam for sedation in adult intensive care patients: a systematic review. Br J Anaesth. 2013 Nov;111(5):703-10. doi: 10.1093/bja/aet194. Epub 2013 Jun 7.
Results Reference
result
PubMed Identifier
22436955
Citation
Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
Results Reference
result
PubMed Identifier
19713256
Citation
Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
Results Reference
result

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

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