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

Alcohol Drinking Clinical Trial

— DEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02197403
• Other study ID #: an00543
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: May 31, 2019

Study information

• Verified date: March 2019
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Anesthesia, Epidural
• Anesthesia, Spinal
• Dexmedetomidine
• Propofol
• Sedation, Conscious

Intervention

Drug:
• Dexmedetomidine
200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion
• Propofol
25~75mcg/kg/min continuous infusion

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanamdo

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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/aet1 — View 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 — View 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 c — View 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 Se — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Every 5 minutes up to 120minutes after drug infusion
Secondary	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	Every 5minutes up to 120minutes after drug infusion
Secondary	Vital signs	Check blood pressure, heart rate, oxygen saturation, bispectral index	During operation