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CompletedNCT04581213PEDICACHEUpdated May 3, 2021

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

An observational study in Anesthesia; Reaction and Children, Only, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by St. Justine's Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
6 Months to 5 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia; Reaction
  • Children, Only

Keywords

  • General anesthesia
  • Children
03

In context

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • 3 unsuccessful attempts of IV access
  • ultrasound device non available
  • neurologic comorbidity
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • ProcedureGeneral anesthesia

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

06

What researchers measure

Primary outcomes

  1. Changes in NIRS values during induction

    Changes in cerebral Near infra-red spectrometry values

    Time frame: baseline and 1 minute after intubation

  2. Changes in cerebral velocity of the middle cerebral artery during induction

    Time frame: baseline and 1 minute after intubation

  3. Changes of Response Entropy (RE) value during induction

    Time frame: baseline and 1 minute after intubation

  4. Changes of State Entropy (SE) value during induction

    Depth of anesthesia

    Time frame: baseline and 1 minute after intubation

Secondary outcomes

  1. Changes in NIRS values after induction

    Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery

  2. 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

  3. Changes of arterial blood pressure during induction

    Time frame: At baseline and 1 minute after intubation

  4. Changes of Response Entropy (RE) values after induction

    Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery

  5. Endtidal Co2 after induction

    Time frame: 1 minute after intubation

  6. Changes of State Entropy (SE) value after induction

    Time frame: At 1 minute, 3 minutes after intubation and at the start of surgery

07

Study locations

1 site
  • Sainte Justine Hospital
    Montreal, Quebec H3T1C5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04581213
Lead sponsor
St. Justine's Hospital
Responsible party
Florent BAUDIN (Principal Investigator, St. Justine's Hospital) — Principal investigator
First posted
Oct 9, 2020
Start date
Aug 24, 2020
Primary completion
Feb 24, 2021
Completion
Feb 24, 2021
Last update
May 3, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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