Skip to main content
Clinical Trials/NCT04581213
NCT04581213
Completed
Not Applicable

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

St. Justine's Hospital1 site in 1 country50 target enrollmentAugust 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia; Reaction
Sponsor
St. Justine's Hospital
Enrollment
50
Locations
1
Primary Endpoint
Changes of State Entropy (SE) value during induction
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2020
End Date
February 24, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Florent BAUDIN

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes of State Entropy (SE) value during induction

Time Frame: baseline and 1 minute after intubation

Depth of anesthesia

Changes in NIRS values during induction

Time Frame: baseline and 1 minute after intubation

Changes in cerebral Near infra-red spectrometry values

Changes of Response Entropy (RE) value during induction

Time Frame: baseline and 1 minute after intubation

Changes in cerebral velocity of the middle cerebral artery during induction

Time Frame: baseline and 1 minute after intubation

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials