Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

NCT04581213 | Completed

• 1 other identifier: 2020_2747
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Reaction; Children, Only

Keywords

General anesthesia; Children

Outcome Measures

Primary Outcomes (4)

• Changes in NIRS values during induction

  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

  baseline and 1 minute after intubation

• Changes of Response Entropy (RE) value during induction

  baseline and 1 minute after intubation

• Changes of State Entropy (SE) value during induction

  Depth of anesthesia

  baseline and 1 minute after intubation

Secondary Outcomes (6)

• Changes in NIRS values 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 arterial blood pressure during induction

  At baseline and 1 minute after intubation

• Changes of Response Entropy (RE) values after induction

  At 1 minute, 3 minutes after intubation and at the start of surgery

• Endtidal Co2 after induction

  1 minute after intubation

Interventions

General anesthesia PROCEDURE

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

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• General anesthesia for elective surgery
• American Society of Anesthesiologists score 1 and 2
• Written informed consent obtained from the parents or legal tutors.

You may not qualify if:

• unsuccessful attempts of IV access
• ultrasound device non available
• neurologic comorbidity

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Sainte Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 9, 2020
• Study Start: August 24, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

CA (1)