Endotracheal IntubationPhase 3NCT00474071
Optimum Dose of Remifentanil for Intubation in Small Children
A Phase 3 study testing Remifentanil in people with Endotracheal Intubation, run by University of British Columbia at 1 site in Canada.
Trial summary
The routine medications to relax the muscles of the throat are an anesthetic drug, propofol, in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used to reduce the amount of propofol required but also to decrease the natural cough reflex to the breathing tube being inserted.The… Read more about this study
- Who is it for?
- Ages Up to 3 weeks
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Remifentanil
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Apr 2008
- Phase
- Phase 3
- 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 Up to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting for routine endotracheal intubation under anesthesia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method
The routine medications to relax the muscles of the throat are an anesthetic drug, propofol, in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used to reduce the amount of propofol required but also to decrease the natural cough reflex to the breathing tube being inserted.The purpose of this study is to find the dose of remifentanil when combined with propofol which provides the best conditions for intubation without cough in infants and small children.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil.
Read the detailed description
The introduction of propofol and short acting opioids has allowed intubation without the use of NMBA to become routine practice. The combination of an opioid and propofol reduces laryngeal reflexes and decreases pressor response to intubation. Identification of the optimum dose combination and sequence of remifentanil-propofol for intubation would allow clinicians to abandon the use of non depolarizing muscle relaxants.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil. The Remifentanil dose will be prepared in a standard fashion by an anesthesiologist not directly involved in the study from the data given to them by a research assistant. The anesthesiologists performing laryngoscopy will be one of the four investigators. There will be a standard starting dose, which must be as close to the population mean as possible. All subjects will receive a minimum dose of 1µg/kg remifentanil which has been shown to produce acceptable intubating conditions.
The dose of remifentanil for the following subject in each group will be determined from the dose used in the previous subject and response to intubation using an" up and down" sequential-allocation technique described by Dixon.
The mean remifentanil intubation dose will be obtained by calculating the midpoint concentration of all independent pairs of patients involving a crossover (ie. Intubation scores all1 to intubation scores not all 1). Mean remifentanil intubation dose would be the average of the crossover midpoints in each subgroup. In addition the standard deviation of remifentanil dose will be the standard deviation of the crossover midpoints in each group. Patient demographics (age/sex/weight), and time to return of spontaneous ventilation will be expressed as mean +/- standard deviation. The inter-group comparisons will be performed using analysis of variance with a difference of 0.5 µg/kg considered to be significant and a p<0.05 considered statistically significant.
- Conditions
- Endotracheal Intubation
- Being tested
- Remifentanil
- Keywords
- Remifentanil, endotracheal intubation, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil intubation dose for ideal intubating conditions
Secondary outcomes (1)
Cardiovascular effects. Time to return to spontaneous ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Mark Ansermino, MD, Principal investigator, University of British ColumbiaHelen Hume-Smith, MD, Study director, University of British ColumbiaCarolyne Montgomery, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474071
- Sponsor's protocol ID
- H06-03467
- Status last verified
- May 2007
- First submitted
- 14 May 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method
- ClinicalTrials.gov ID
- NCT00474071
- Acronym / sponsor ID
- H06-03467
- Conditions
- Endotracheal Intubation
- Keywords
- Remifentanil, endotracheal intubation, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 May 2007 (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 routine medications to relax the muscles of the throat are an anesthetic drug, propofol, in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used to reduce the amount of propofol required but also to decrease the natural cough reflex to the breathing tube being inserted.The purpose of this study is to find the dose of remifentanil when combined with propofol which provides the best conditions for intubation without cough in infants and small children.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil.
Detailed description
The introduction of propofol and short acting opioids has allowed intubation without the use of NMBA to become routine practice. The combination of an opioid and propofol reduces laryngeal reflexes and decreases pressor response to intubation. Identification of the optimum dose combination and sequence of remifentanil-propofol for intubation would allow clinicians to abandon the use of non depolarizing muscle relaxants.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil. The Remifentanil dose will be prepared in a standard fashion by an anesthesiologist not directly involved in the study from the data given to them by a research assistant. The anesthesiologists performing laryngoscopy will be one of the four investigators. There will be a standard starting dose, which must be as close to the population mean as possible. All subjects will receive a minimum dose of 1µg/kg remifentanil which has been shown to produce acceptable intubating conditions.
The dose of remifentanil for the following subject in each group will be determined from the dose used in the previous subject and response to intubation using an" up and down" sequential-allocation technique described by Dixon.
The mean remifentanil intubation dose will be obtained by calculating the midpoint concentration of all independent pairs of patients involving a crossover (ie. Intubation scores all1 to intubation scores not all 1). Mean remifentanil intubation dose would be the average of the crossover midpoints in each subgroup. In addition the standard deviation of remifentanil dose will be the standard deviation of the crossover midpoints in each group. Patient demographics (age/sex/weight), and time to return of spontaneous ventilation will be expressed as mean +/- standard deviation. The inter-group comparisons will be performed using analysis of variance with a difference of 0.5 µg/kg considered to be significant and a p<0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- Up to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presenting for routine endotracheal intubation under anesthesia.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RemifentanilSee Detailed Description. | Drug | – |
Primary outcome
Remifentanil intubation dose for ideal intubating conditions
1 secondary outcome
Cardiovascular effects. Time to return to spontaneous ventilation.
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 Sep 2008.
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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.
Mark Ansermino, MD principal investigator
University of British Columbia
Helen Hume-Smith, MD study director
University of British Columbia
Carolyne Montgomery, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil in people with Endotracheal Intubation, run by University of British Columbia at 1 site in Canada.
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 0 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 Sep 2008. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Remifentanil intubation dose for ideal intubating conditions. 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 Sep 2008.