Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Children, Only Clinical Trial

— PEDICACHE  

Official title:

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581213
• Other study ID #: 2020_2747
• Status: Completed
• Start date: August 24, 2020
• Est. completion date: February 24, 2021

Study information

• Verified date: April 2021
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Children, Only

Intervention

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

Locations

Country	Name	City	State
Canada	Sainte Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in NIRS values during induction	Changes in cerebral Near infra-red spectrometry values	baseline and 1 minute after intubation
Primary	Changes in cerebral velocity of the middle cerebral artery during induction		baseline and 1 minute after intubation
Primary	Changes of Response Entropy (RE) value during induction		baseline and 1 minute after intubation
Primary	Changes of State Entropy (SE) value during induction	Depth of anesthesia	baseline and 1 minute after intubation
Secondary	Changes in NIRS values after induction		At 1 minute, 3 minutes after intubation and at the start of surgery
Secondary	Change in cerebral velocity of the middle cerebral artery after induction		At 1 minute, 3 minutes after intubation and at the start of surgery
Secondary	Changes of arterial blood pressure during induction		At baseline and 1 minute after intubation
Secondary	Changes of Response Entropy (RE) values after induction		At 1 minute, 3 minutes after intubation and at the start of surgery
Secondary	Endtidal Co2 after induction		1 minute after intubation
Secondary	Changes of State Entropy (SE) value after induction		At 1 minute, 3 minutes after intubation and at the start of surgery