Pediatric Urinary DisordersNCT01084031
Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
A study testing propofol in people with Pediatric Urinary Disorders, run by Yonsei University.
Trial summary
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Pediatric Urinary Disorders
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients scheduled for elective day case surgery were enrolled.
Who cannot join
- History of obstructive sleep apnea
- Evidence of cardiorespiratory disease
- Those who were obese or allergic to any of the anesthetic agents in this study
- Those with an anticipated difficult airway, full stomach
- History of malignant hyperthermia or other myopathy were excluded.
About this study
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.
- Conditions
- Pediatric Urinary Disorders
- Being tested
- propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
intravenous propofol with sevoflurane inhalation induction
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intubation conditions
Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods.
peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)
Measured: 30 minutes after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Urinary DisordersStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hae Keum Kil, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084031
- Sponsor's protocol ID
- 4-2009-0470
- Status last verified
- Feb 2014
- First submitted
- 5 Mar 2010
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
- ClinicalTrials.gov ID
- NCT01084031
- Acronym / sponsor ID
- 4-2009-0470
- Conditions
- Pediatric Urinary Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Mar 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.
Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: propofol |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients scheduled for elective day case surgery were enrolled.
Key exclusion criteria (5 listed)
- History of obstructive sleep apnea
- Evidence of cardiorespiratory disease
- Those who were obese or allergic to any of the anesthetic agents in this study
- Those with an anticipated difficult airway, full stomach
- History of malignant hyperthermia or other myopathy were excluded.
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 |
|---|---|---|
| propofolintravenous propofol with sevoflurane inhalation induction | Drug | propofol |
Primary outcome
Assessment of intubation conditions
Time frame: 30 minutes after the surgery
Assessment of intubation conditions (vocal cord, intubation condition, cough, movement) , peri-induction HR and BP change, post-operative agitation socre at recovery room. ED50 and ED 95 of each group by uring Dixon's up and down methods. peri -induction period -comparison of above factors among each groups (GroupA: ETSevo 3vol%, Group B: ETSevo 3.5vol%, Group: ET Sevo 4vol%)
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 19 Feb 2014.
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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.
Hae Keum Kil principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
A study testing propofol in people with Pediatric Urinary Disorders, run by Yonsei University.
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: finished, as of the sponsor's last update on 19 Feb 2014. 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?
Assessment of intubation conditions (time frame: 30 minutes after the surgery). 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 19 Feb 2014.