Effect of Anesthesia Induction on Cerebral Hemodynamic in Children (PEDICACHE)

April 30, 2021 updated by: Florent BAUDIN, St. Justine's Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1C5
        • Sainte Justine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in NIRS values during induction
Time Frame: baseline and 1 minute after intubation
Changes in cerebral Near infra-red spectrometry values
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
baseline and 1 minute after intubation
Changes of Response Entropy (RE) value during induction
Time Frame: baseline and 1 minute after intubation
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
baseline and 1 minute after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in NIRS values after induction
Time Frame: At 1 minute, 3 minutes after intubation and at the start of surgery
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
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
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
At 1 minute, 3 minutes after intubation and at the start of surgery
Endtidal Co2 after induction
Time Frame: 1 minute after intubation
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
At 1 minute, 3 minutes after intubation and at the start of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

February 24, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_2747

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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