Anesthesia, SpinalPhase 4DEXNCT02197403
Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker
A Phase 4 study testing Dexmedetomidine and Propofol in people with Anesthesia, Spinal and Sedation, Conscious, run by Chonnam National University Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to 31 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19~65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanamdo, 501-757
Changbeom Park, Master, 82-61-379-7598, cnuhpch@naver.com
Hyunjung Lee, M.D, master
About this study
Official title: Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
- 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
Read the 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.
- Conditions
- Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine, Alcohol Drinking, Anesthesia, Epidural, Propofol
- Being tested
- Dexmedetomidine, Propofol
- Keywords
- Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion
PropofolDrug
Also called Fresofol
25~75mcg/kg/min continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| alcohol drinker & dexmedetomidine | Experimental | dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery Receives: Drug: Dexmedetomidine |
| alcohol drinker & propofol | Active comparator | Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion Receives: Drug: Propofol |
| Non-alcohol drinker & dexmedetomidine | Active comparator | dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery Receives: Drug: Dexmedetomidine |
| Non-alcohol drinker & propofol | Active comparator | Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 5 minutes up to 120minutes after drug infusion
Secondary outcomes (2)
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
Measured: Every 5minutes up to 120minutes after drug infusion
Vital signs
Check blood pressure, heart rate, oxygen saturation, bispectral index
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startDec 2013
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-il Choi, Chonnam National University Hospital
- Investigators
- Hyunjung Lee, MD, Master, Principal investigator, Chonnam National University HospitalJeongil Choi, MD, PhD, Study director, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197403
- Sponsor's protocol ID
- an00543
- Acronym
- DEX
- Status last verified
- Mar 2019
- First submitted
- 21 Jul 2014
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21903640Adams 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.
PubMed 23748199Jakob 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.
PubMed 22436955Candiotti 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.
PubMed 19713256
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
- ClinicalTrials.gov ID
- NCT02197403
- Acronym / sponsor ID
- DEX / an00543
- Conditions
- Anesthesia, Spinal, Sedation, Conscious, Dexmedetomidine, Alcohol Drinking, Anesthesia, Epidural, Propofol
- Keywords
- Dexmedetomidine, Sedation, Paradoxical excitement response, Alcohol drinkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| alcohol drinker & dexmedetomidine | Experimental | Drug: Dexmedetomidinedexmedetomidine, 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 comparator | Drug: PropofolPropofol (2% fresofol) 25~75mcg/kg/min continuous infusion |
| Non-alcohol drinker & dexmedetomidine | Active comparator | Drug: Dexmedetomidinedexmedetomidine, 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 comparator | Drug: PropofolPropofol (2% fresofol) 25~75mcg/kg/min continuous infusion |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 19~65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion | Drug | Non-alcohol drinker & dexmedetomidine, alcohol drinker & dexmedetomidine |
| PropofolAlso: Fresofol25~75mcg/kg/min continuous infusion | Drug | Non-alcohol drinker & propofol, alcohol drinker & propofol |
Primary outcome
Paradoxical excitement response
Time frame: Every 5 minutes up to 120minutes after drug infusion
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
2 secondary outcomes
OAA/S
Time frame: Every 5minutes up to 120minutes after drug infusion
Vital signs
Time frame: During operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Results publication: PubMed 21903640Jeong 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 publication: PubMed 23748199Adams 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 publication: PubMed 22436955Jakob 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 publication: PubMed 19713256Candiotti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunjung Lee, MD, Master principal investigator
Chonnam National University Hospital
Jeongil Choi, MD, PhD study director
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol in people with Anesthesia, Spinal and Sedation, Conscious, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paradoxical excitement response (time frame: Every 5 minutes up to 120minutes after drug infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197403, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.