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OpenTrials
Completed

NCT Number: NCT04581213

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

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.

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Key information

Conditions

Anesthesia; Reaction Children, Only

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sainte Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia

Procedure

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

Primary outcomes

  1. Changes in NIRS values during induction

    Time frame: 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

    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

    Time frame: baseline and 1 minute after intubation

    Depth of anesthesia

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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Acronym: PEDICACHE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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