Psychomotor AgitationPhase 4NCT01578161
The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
A Phase 4 study testing Dexmedetomidine and 0.9% Normal Saline in people with Psychomotor Agitation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Agitation
- What is being tested?
- Dexmedetomidine and 0.9% Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Apr 2013
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Physical status classification of American Society of Anesthesiologist 1-2,
- Healthy, normal
- 2-6 years old
- Elective operation
Who cannot join
- Lack of consent
- Known adverse effects to dexmedetomidine, mental retardation
- Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
- No cardiac disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL
SungNam-si, Kyonggi Do, 463-707
SangHwan Do, 82-31-787-7499, shdo@snubh.org
AhYoung Oh
About this study
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.
Read the detailed description
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
- Conditions
- Psychomotor Agitation
- Being tested
- Dexmedetomidine, 0.9% Normal Saline
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
0.9% Normal SalineDrug
Placebo,Normal saline 10ml ivs. for 10min.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine0.25 | Experimental | dexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine0.5 | Experimental | dexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine1.0 | Experimental | dexmedetomidine 1 microg.kg(-1) ivs. for 10min. Receives: Drug: Dexmedetomidine |
| NormalSaline | Placebo comparator | Normal saline 10ml ivs. for 10min. Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation score
Measured: 30 mins after operation
Secondary outcomes (1)
Oculomotor reflex
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ah-Young Oh, Seoul National University Hospital
- Investigators
- AhYoung Oh, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578161
- Sponsor's protocol ID
- SNUBH_01
- Status last verified
- Apr 2012
- First submitted
- 13 Apr 2012
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT01578161
- Acronym / sponsor ID
- SNUBH_01
- Conditions
- Psychomotor Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 16 Apr 2012 (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.
After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.
Detailed description
There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine0.25 | Experimental | Drug: Dexmedetomidinedexmedetomidine 0.25 microg.kg(-1),(Group D0.25) ivs. for 10min. |
| Dexmedetomidine0.5 | Experimental | Drug: Dexmedetomidinedexmedetomidine 0.5 microg.kg(-1),(group D0.5) ivs. for 10min. |
| Dexmedetomidine1.0 | Experimental | Drug: Dexmedetomidinedexmedetomidine 1 microg.kg(-1) ivs. for 10min. |
| NormalSaline | Placebo comparator | Drug: 0.9% Normal SalineNormal saline 10ml ivs. for 10min. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physical status classification of American Society of Anesthesiologist 1-2,
- Healthy, normal
- 2-6 years old
- Elective operation
Key exclusion criteria (4 listed)
- Lack of consent
- Known adverse effects to dexmedetomidine, mental retardation
- Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
- No cardiac disease
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: PrecedexThere are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient. | Drug | Dexmedetomidine0.25, Dexmedetomidine0.5, Dexmedetomidine1.0 |
| 0.9% Normal SalinePlacebo,Normal saline 10ml ivs. for 10min. | Drug | NormalSaline |
Primary outcome
Agitation score
Time frame: 30 mins after operation
1 secondary outcome
Oculomotor reflex
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
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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.
AhYoung Oh principal investigator
Seoul National University Bundang 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 0.9% Normal Saline in people with Psychomotor Agitation, run by Seoul 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 4 inclusion and 4 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 16 Apr 2012. 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. Some participants in this study may receive a placebo. 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?
Contact INAE SONG (82-10-2609-2401, nodame1@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation score (time frame: 30 mins after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2012.