AgitationNCT01517438
Effects of Serotonin Inhibitors on Patient-controlled Analgesia Related Nausea and Vomiting
A study testing agitation in people with Agitation, run by Seoul National University Hospital.
Trial summary
ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Agitation
- What is being tested?
- agitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2011
- Phase
- Interventional
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- tonsillectomy or adenoidectomy
Who cannot join
- development delay,
- CNS abnormality
About this study
ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children
- Conditions
- Agitation
- Being tested
- agitation
- Keywords
- agitation, desflurane, children
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agitationBehavioural
agitation score after desflurane anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
agitation score
agitation score
Measured: 30 minutes after postoperatuib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517438
- Sponsor's protocol ID
- ramosetron
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serotonin Inhibitors on Patient-controlled Analgesia Related Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01517438
- Acronym / sponsor ID
- ramosetron
- Conditions
- Agitation
- Keywords
- agitation, desflurane, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 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.
ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- tonsillectomy or adenoidectomy
Key exclusion criteria (2 listed)
- development delay,
- CNS abnormality
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 |
|---|---|---|
| agitationagitation score after desflurane anesthesia | Behavioural | – |
Primary outcome
agitation score
Time frame: 30 minutes after postoperatuib
agitation score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
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Healthy Adult Participants
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing agitation in people with Agitation, run by Seoul National University Hospital.
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 2 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: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agitation score (time frame: 30 minutes after postoperatuib). 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 25 Jan 2012.