Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Completed

• Conditions: Children, Only; Anesthesia; Reaction

• Registration Number: NCT04581213
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-09
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of State Entropy (SE) value during induction	baseline and 1 minute after intubation	Depth of anesthesia
Changes in NIRS values during induction	baseline and 1 minute after intubation	Changes in cerebral Near infra-red spectrometry values
Changes of Response Entropy (RE) value during induction	baseline and 1 minute after intubation
Changes in cerebral velocity of the middle cerebral artery during induction	baseline and 1 minute after intubation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sainte Justine Hospital; 🇨🇦 Montreal, Quebec, Canada