Anesthesia; ReactionPEDICACHENCT04581213
Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
An observational study of Anesthesia; Reaction and Children, Only, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Anesthesia; Reaction, Children, Only
- What is being tested?
- General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2020to 24 Feb 2021
- Phase
- Observational
- 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
Study population: Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.
Who may be able to join
- General anesthesia for elective surgery
- American Society of Anesthesiologists score 1 and 2
- Written informed consent obtained from the parents or legal tutors.
Who cannot join
- 3 unsuccessful attempts of IV access
- ultrasound device non available
- neurologic comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial doppler), and the depth of anesthesia in children between 6 months and 5 years old during the induction of general anesthesia (induced with sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be maintained despite systemic variations.
- Conditions
- Anesthesia; Reaction, Children, Only
- Being tested
- General anesthesia
- Keywords
- General anesthesia, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in NIRS values during induction
Changes in cerebral Near infra-red spectrometry values
Measured: baseline and 1 minute after intubation
Changes in cerebral velocity of the middle cerebral artery during induction
Measured: baseline and 1 minute after intubation
Changes of Response Entropy (RE) value during induction
Measured: baseline and 1 minute after intubation
Changes of State Entropy (SE) value during induction
Depth of anesthesia
Measured: baseline and 1 minute after intubation
Secondary outcomes (6)
Changes in NIRS values after induction
Measured: At 1 minute, 3 minutes after intubation and at the start of surgery
Change in cerebral velocity of the middle cerebral artery after induction
Measured: At 1 minute, 3 minutes after intubation and at the start of surgery
Changes of arterial blood pressure during induction
Measured: At baseline and 1 minute after intubation
Changes of Response Entropy (RE) values after induction
Measured: At 1 minute, 3 minutes after intubation and at the start of surgery
Endtidal Co2 after induction
Measured: 1 minute after intubation
Changes of State Entropy (SE) value after induction
Measured: At 1 minute, 3 minutes after intubation and at the start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start24 Aug 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florent BAUDIN, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581213
- Sponsor's protocol ID
- 2020_2747
- Acronym
- PEDICACHE
- Status last verified
- Apr 2021
- First submitted
- 16 Sep 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
- ClinicalTrials.gov ID
- NCT04581213
- Acronym / sponsor ID
- PEDICACHE / 2020_2747
- Conditions
- Anesthesia; Reaction, Children, Only
- Keywords
- General anesthesia, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- 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.
General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial doppler), and the depth of anesthesia in children between 6 months and 5 years old during the induction of general anesthesia (induced with sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be maintained despite systemic variations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.
Key inclusion criteria (3 listed)
- General anesthesia for elective surgery
- American Society of Anesthesiologists score 1 and 2
- Written informed consent obtained from the parents or legal tutors.
Key exclusion criteria (3 listed)
- 3 unsuccessful attempts of IV access
- ultrasound device non available
- neurologic comorbidity
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 |
|---|---|---|
| General anesthesiaChildren under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2. | Procedure or surgery | – |
Primary outcome
Changes in NIRS values during induction
Time frame: baseline and 1 minute after intubation
Changes in cerebral Near infra-red spectrometry values
Changes in cerebral velocity of the middle cerebral artery during induction
Time frame: baseline and 1 minute after intubation
Changes of Response Entropy (RE) value during induction
Time frame: baseline and 1 minute after intubation
Changes of State Entropy (SE) value during induction
Time frame: baseline and 1 minute after intubation
Depth of anesthesia
6 secondary outcomes
Changes in NIRS values after induction
Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery
Change in cerebral velocity of the middle cerebral artery after induction
Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery
Changes of arterial blood pressure during induction
Time frame: At baseline and 1 minute after intubation
Changes of Response Entropy (RE) values after induction
Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery
Endtidal Co2 after induction
Time frame: 1 minute after intubation
Changes of State Entropy (SE) value after induction
Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery
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 3 May 2021.
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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?
An observational study of Anesthesia; Reaction and Children, Only, run by St. Justine's Hospital 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 3 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 3 May 2021. 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.
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?
Changes in NIRS values during induction (time frame: baseline and 1 minute after intubation). The study lists 4 primary outcomes in all. 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 3 May 2021.