HealthyNCT01152476
Emergency Agitation in T&A
A study testing remifentanil and normal saline in people with Healthy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Healthy
- What is being tested?
- remifentanil and normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Oct 2010
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologist physical status I or II
- 2-6 year-old children
- patients undergoing tonsillectomy and adenoidectomy
Who cannot join
- upper respiratory disease
- mental retardation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.
- Conditions
- Healthy
- Being tested
- remifentanil, normal saline
- Keywords
- healthy pediatric patients undergoing tonsillectomy and adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
General anesthesia is maintained witn sevoflurane and remifentanil.
normal salineDrug
General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil
| Study group | Role | What they receive |
|---|---|---|
| group SR | Active comparator | Not described Receives: Drug: remifentanil |
| group S | Active comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergency agitation
at post-anesthetic care unit
Measured: during 1 hour after recovering of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152476
- Sponsor's protocol ID
- T&A_EA
- Status last verified
- Jan 2011
- First submitted
- 25 Jun 2010
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Agitation in T&A
- ClinicalTrials.gov ID
- NCT01152476
- Acronym / sponsor ID
- T&A_EA
- Conditions
- Healthy
- Keywords
- healthy pediatric patients undergoing tonsillectomy and adenoidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jun 2010 (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.
Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group SR | Active comparator | Drug: remifentanil |
| group S | Active comparator | Drug: normal saline |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist physical status I or II
- 2-6 year-old children
- patients undergoing tonsillectomy and adenoidectomy
Key exclusion criteria (2 listed)
- upper respiratory disease
- mental retardation
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 |
|---|---|---|
| remifentanilGeneral anesthesia is maintained witn sevoflurane and remifentanil. | Drug | group SR |
| normal salineGeneral anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil | Drug | group S |
Primary outcome
emergency agitation
Time frame: during 1 hour after recovering of anesthesia
at post-anesthetic care unit
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 6 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remifentanil and normal saline in people with Healthy, run by Seoul National University Bundang 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 3 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 6 Jan 2011. 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.
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?
emergency agitation (time frame: during 1 hour after recovering of anesthesia). 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 6 Jan 2011.