Respiratory ComplicationNCT01919203
the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children
A study testing Remifentanil in people with Respiratory Complication, run by Sangjin Park at 1 site in South Korea.
Trial summary
This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Respiratory Complication
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Jul 2015
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists physical status 1 or 2
- undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia
Who cannot join
- suspected difficult airways
- respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
- body mass index > 30 kg/m2
- allergies to the study drugs
- a history of gastric reflux
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Nam Gu, Daegu, 705-035
About this study
Official title: the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Pediatric Patients
This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.
Read the detailed description
Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
- Conditions
- Respiratory Complication
- Being tested
- Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called remifentanil (ultiva)
The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
| Study group | Role | What they receive |
|---|---|---|
| group R | Experimental | The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients's response to the LMA insertion
Fail of LMA insertion is defined as body or limb movement, coughing or gagging with 2 minutes after LMA insertion, no proper jaw relaxation(difficult mouth opening), laryngospasm, bronchospasm, desaturation(SpO2<94%)
Measured: 2 minutes after LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ComplicationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangjin Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sangjin Park, Yeungnam University College of Medicine
- Investigators
- sangjin park, M.D., Principal investigator, Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919203
- Sponsor's protocol ID
- apsj0723
- Status last verified
- Jul 2015
- First submitted
- 7 Aug 2013
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01919203
- Acronym / sponsor ID
- apsj0723
- Conditions
- Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sangjin ParkUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Aug 2013 (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.
This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.
Detailed description
Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group R | Experimental | Drug: RemifentanilThe starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1 or 2
- undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia
Key exclusion criteria (5 listed)
- suspected difficult airways
- respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
- body mass index > 30 kg/m2
- allergies to the study drugs
- a history of gastric reflux
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 |
|---|---|---|
| RemifentanilAlso: remifentanil (ultiva)The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively. | Drug | group R |
Primary outcome
patients's response to the LMA insertion
Time frame: 2 minutes after LMA insertion
Fail of LMA insertion is defined as body or limb movement, coughing or gagging with 2 minutes after LMA insertion, no proper jaw relaxation(difficult mouth opening), laryngospasm, bronchospasm, desaturation(SpO2<94%)
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 16 Jul 2015.
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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.
sangjin park, M.D. principal investigator
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
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 in people with Respiratory Complication, run by Sangjin Park 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 2 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: finished, as of the sponsor's last update on 16 Jul 2015. 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?
patients's response to the LMA insertion (time frame: 2 minutes after LMA insertion). 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 Jul 2015.