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Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04581213
Acronym
PEDICACHE
Enrollment
50
Registered
2020-10-09
Start date
2020-08-24
Completion date
2021-02-24
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Reaction, Children, Only

Keywords

General anesthesia, Children

Brief 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 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.

Interventions

PROCEDUREGeneral anesthesia

Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

Inclusion criteria

* General anesthesia for elective surgery * American Society of Anesthesiologists score 1 and 2 * Written informed consent obtained from the parents or legal tutors.

Exclusion criteria

* 3 unsuccessful attempts of IV access * ultrasound device non available * neurologic comorbidity

Design outcomes

Primary

MeasureTime frameDescription
Changes in NIRS values during inductionbaseline and 1 minute after intubationChanges in cerebral Near infra-red spectrometry values
Changes in cerebral velocity of the middle cerebral artery during inductionbaseline and 1 minute after intubation
Changes of Response Entropy (RE) value during inductionbaseline and 1 minute after intubation
Changes of State Entropy (SE) value during inductionbaseline and 1 minute after intubationDepth of anesthesia

Secondary

MeasureTime frame
Endtidal Co2 after induction1 minute after intubation
Changes in NIRS values after inductionAt 1 minute, 3 minutes after intubation and at the start of surgery
Changes of State Entropy (SE) value after inductionAt 1 minute, 3 minutes after intubation and at the start of surgery
Change in cerebral velocity of the middle cerebral artery after inductionAt 1 minute, 3 minutes after intubation and at the start of surgery
Changes of arterial blood pressure during inductionAt baseline and 1 minute after intubation
Changes of Response Entropy (RE) values after inductionAt 1 minute, 3 minutes after intubation and at the start of surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026