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PEDICACHE: Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Sponsor
St. Justine's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04581213
Collaborator
(none)
50
Enrollment
1
Location
6
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: General anesthesia

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
Actual Study Start Date :
Aug 24, 2020
Actual Primary Completion Date :
Feb 24, 2021
Actual Study Completion Date :
Feb 24, 2021

Outcome Measures

Primary Outcome Measures

  1. Changes in NIRS values during induction [baseline and 1 minute after intubation]

    Changes in cerebral Near infra-red spectrometry values

  2. Changes in cerebral velocity of the middle cerebral artery during induction [baseline and 1 minute after intubation]

  3. Changes of Response Entropy (RE) value during induction [baseline and 1 minute after intubation]

  4. Changes of State Entropy (SE) value during induction [baseline and 1 minute after intubation]

    Depth of anesthesia

Secondary Outcome Measures

  1. Changes in NIRS values after induction [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 [At 1 minute, 3 minutes after intubation and at the start of surgery]

  3. Changes of arterial blood pressure during induction [At baseline and 1 minute after intubation]

  4. Changes of Response Entropy (RE) values after induction [At 1 minute, 3 minutes after intubation and at the start of surgery]

  5. Endtidal Co2 after induction [1 minute after intubation]

  6. Changes of State Entropy (SE) value after induction [At 1 minute, 3 minutes after intubation and at the start of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sainte Justine Hospital Montreal Quebec Canada H3T1C5

Sponsors and Collaborators

  • St. Justine's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Florent BAUDIN, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT04581213
Other Study ID Numbers:
  • 2020_2747
First Posted:
Oct 9, 2020
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Florent BAUDIN, Principal Investigator, St. Justine's Hospital
General anesthesia
Children
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of May 3, 2021