Children Under General AnesthesiaPhase 4NCT01411020
Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia
A Phase 4 study testing endotracheal intubation in people with Children Under General Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Children Under General Anesthesia
- What is being tested?
- endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- Oct 2009to Nov 2012
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- obtained informed consent
- children between 3 and 11 years
- healthy
- elective surgery under general anesthesia
- no premedication
Who cannot join
- body mass index for age > 95th percentile
- chronic or acute intake of any sedative drug
- any known adverse effect to the study drugs
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Universidad Catolica
Santiago, Santiago Metropolitan
About this study
Official title: Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years
The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia.
- Conditions
- Children Under General Anesthesia
- Being tested
- endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubationProcedure or surgery
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
| Study group | Role | What they receive |
|---|---|---|
| Grupo 1 | Experimental | Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 2 | Experimental | Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 3 | Experimental | Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 4 | Experimental | Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 5 | Experimental | Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 6 | Experimental | Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 7 | Experimental | Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 8 | Experimental | Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 9 | Experimental | Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg Receives: Procedure: endotracheal intubation |
| Grupo 10 | Experimental | Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg Receives: Procedure: endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose of propofol
to obtain a dose appropriate of propofol in induction of anesthesia
Measured: two days (duration of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411020
- Sponsor's protocol ID
- Ricardo Fuentes
- Other IDs
- Hernan Muñoz
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2011
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Munoz HR, Leon PJ, Fuentes RS, Echevarria GC, Cortinez LI. Prospective evaluation of the time to peak effect of propofol to target the effect site in children. Acta Anaesthesiol Scand. 2009 Aug;53(7):883-90. doi: 10.1111/j.1399-6576.2009.01995.x. Epub 2009 Jun 3.
PubMed 19496767
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years
- ClinicalTrials.gov ID
- NCT01411020
- Acronym / sponsor ID
- Ricardo Fuentes
- Conditions
- Children Under General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Aug 2011 (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.
The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Grupo 1 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg |
| Grupo 2 | Experimental | Procedure: endotracheal intubationDose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg |
| Grupo 3 | Experimental | Procedure: endotracheal intubationDoses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg |
| Grupo 4 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg |
| Grupo 5 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg |
| Grupo 6 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg |
| Grupo 7 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg |
| Grupo 8 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg |
| Grupo 9 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg |
| Grupo 10 | Experimental | Procedure: endotracheal intubationDoses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- obtained informed consent
- children between 3 and 11 years
- healthy
- elective surgery under general anesthesia
- no premedication
Key exclusion criteria (3 listed)
- body mass index for age > 95th percentile
- chronic or acute intake of any sedative drug
- any known adverse effect to the study drugs
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 |
|---|---|---|
| endotracheal intubationto perform endotracheal intubation if number of bispectral index (BIS) is 40-60, | Procedure or surgery | Grupo 1, Grupo 10, Grupo 2, Grupo 3, Grupo 4, Grupo 5, Grupo 6, Grupo 7, Grupo 8, Grupo 9 |
Primary outcome
dose of propofol
Time frame: two days (duration of hospitalization)
to obtain a dose appropriate of propofol in induction of anesthesia
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 15 May 2013.
- Background: PubMed 19496767Munoz HR, Leon PJ, Fuentes RS, Echevarria GC, Cortinez LI. Prospective evaluation of the time to peak effect of propofol to target the effect site in children. Acta Anaesthesiol Scand. 2009 Aug;53(7):883-90. doi: 10.1111/j.1399-6576.2009.01995.x. Epub 2009 Jun 3.
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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 Phase 4 study testing endotracheal intubation in people with Children Under General Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 3 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 15 May 2013. 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 Chile. 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.
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?
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?
dose of propofol (time frame: two days (duration of hospitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411020, which also lists 1 linked publication.
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 15 May 2013.