Clinical trial NCT02197403: Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
Official title: Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Spinal
Sedation, Conscious
Dexmedetomidine
Alcohol Drinking
Anesthesia, Epidural
Propofol
Keywords: Dexmedetomidine
Sedation
Paradoxical excitement response
Alcohol drinkers
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Paradoxical excitement response
timeFrame: Every 5 minutes up to 120minutes after drug infusion
Secondary outcomes:
measure: OAA/S
timeFrame: Every 5minutes up to 120minutes after drug infusion
measure: Vital signs
timeFrame: During operation
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanamdo
Study officials:
affiliation: Chonnam National University Hospital
name: Hyunjung Lee, MD, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jeongil Choi, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.