Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
DEX
Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
1 other identifier
interventional
110
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedMarch 14, 2019
March 1, 2019
5.5 years
July 21, 2014
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Paradoxical excitement response
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 Outcomes (2)
OAA/S
Every 5minutes up to 120minutes after drug infusion
Vital signs
During operation
Study Arms (4)
alcohol drinker & dexmedetomidine
EXPERIMENTALdexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery
alcohol drinker & propofol
ACTIVE COMPARATORPropofol (2% fresofol) 25\~75mcg/kg/min continuous infusion
Non-alcohol drinker & dexmedetomidine
ACTIVE COMPARATORdexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion during surgery
Non-alcohol drinker & propofol
ACTIVE COMPARATORPropofol (2% fresofol) 25\~75mcg/kg/min continuous infusion
Interventions
200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion
25\~75mcg/kg/min continuous infusion
Eligibility Criteria
You may qualify if:
- \~65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo, 501-757, South Korea
Related Publications (4)
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.
PMID: 21903640RESULTAdams 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.
PMID: 23748199RESULTJakob 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.
PMID: 22436955RESULTCandiotti 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.
PMID: 19713256RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyunjung Lee, MD, Master
Chonnam National University Hospital
- STUDY DIRECTOR
Jeongil Choi, MD, PhD
Chonnam National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2014
First Posted
July 22, 2014
Study Start
December 1, 2013
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
March 14, 2019
Record last verified: 2019-03