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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion

alcohol drinker & propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

25\~75mcg/kg/min continuous infusion

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion

Non-alcohol drinker & propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

25\~75mcg/kg/min continuous infusion

Interventions

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Dexmedetomidine

200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1\~1.0mcg/Kg infusion

Intervention Type DRUG

Propofol

25\~75mcg/kg/min continuous infusion

Intervention Type DRUG

Other Intervention Names

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Precedex Fresofol

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No