AnesthesiaNCT02806596
Bispectral Index to Guide Intubation in Pediatric Anesthesia
A study testing Sevoflurane in people with Anesthesia, run by University of Liege.
Trial summary
This prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2013
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society Anesthesiology physical status classification system :1 or 2
- scheduled ear, nose and throat surgery in a one day program
- oral intubation required
Who cannot join
- parents refusal
- recent respiratory infection
- epilepsy
- suspected difficult intubation
About this study
Official title: Use of Bispectral Index to Guide Intubation During Sevoflurane Anesthesia in Children
This prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children.
Read the detailed description
- Children will received intra-rectal premedication based on midazolam 0.4mg
- Children will be monitored according to standard guidelines
- One blinded anesthesiologist will be in charge of anesthesia induction and the other one will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane minimal alveolar concentration, bispectral index) and guidance of induction according to the predetermined bispectral index (up and down allocation)
- Conditions
- Anesthesia
- Being tested
- Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
After at least 4 minutes of stable inspired sevoflurane concentration, that concentration will be titrated to obtain a targeted bispectral index (BIS) level required for perform laryngoscopy. This level was initially set at 40, based on a preliminary study showing that such level of BIS was obtained at the laryngoscopy after common general anesthesia induction. For the next patients, BIS target was set according to a sequential allocation method (up and down).
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Other | * induction of anesthesia using sevoflurane administered with facial mask at inspired concentration of 6% (in a mixture of oxygen and nitrous oxyde)
* intervention : titration of inspired sevoflurane concentration until targeted bispectral index Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngeal conditions of intubation
specific conditions will be assessed and scored : jaw relaxation, vocal cord position, cough at intubation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Hallet, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806596
- Sponsor's protocol ID
- BIS02ch
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: data will not been shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bispectral Index to Guide Intubation During Sevoflurane Anesthesia in Children
- ClinicalTrials.gov ID
- NCT02806596
- Acronym / sponsor ID
- BIS02ch
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jun 2016 (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 prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children.
Detailed description
- Children will received intra-rectal premedication based on midazolam 0.4mg
- Children will be monitored according to standard guidelines
- One blinded anesthesiologist will be in charge of anesthesia induction and the other one will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane minimal alveolar concentration, bispectral index) and guidance of induction according to the predetermined bispectral index (up and down allocation)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Other | Drug: Sevoflurane* induction of anesthesia using sevoflurane administered with facial mask at inspired concentration of 6% (in a mixture of oxygen and nitrous oxyde) * intervention : titration of inspired sevoflurane concentration until targeted bispectral index |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society Anesthesiology physical status classification system :1 or 2
- scheduled ear, nose and throat surgery in a one day program
- oral intubation required
Key exclusion criteria (4 listed)
- parents refusal
- recent respiratory infection
- epilepsy
- suspected difficult intubation
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 |
|---|---|---|
| SevofluraneAfter at least 4 minutes of stable inspired sevoflurane concentration, that concentration will be titrated to obtain a targeted bispectral index (BIS) level required for perform laryngoscopy. This level was initially set at 40, based on a preliminary study showing that such level of BIS was obtained at the laryngoscopy after common general anesthesia induction. For the next patients, BIS target was set according to a sequential allocation method (up and down). | Drug | sevoflurane |
Primary outcome
laryngeal conditions of intubation
Time frame: 5 minutes
specific conditions will be assessed and scored : jaw relaxation, vocal cord position, cough at intubation
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 29 Jun 2016.
- Individual participant dataSharing planned: No. data will not been shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Anesthesia, run by University of Liege.
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 4 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 29 Jun 2016. 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?
laryngeal conditions of intubation (time frame: 5 minutes). 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 29 Jun 2016.